Online & Distance Industry Program in ... - NCK Pharma · NCK Pharma Solution Private Limited is the accredited by International Association of Distance Learning, UK. 3. R ... All

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Accredited By:International Association of Dsiatnce Learning

Online & Distance Industry Program in Pharmaceutical,

Biopharmaceutical & Medical Devices

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NCK Pharma Solution Private LimitedWorld Trade Center, 22nd floor, Unit No. N 2201, Brigade Gateway Campus, No.26/1, Dr.Rajkumar Road, Malleswaram West,Bangalore - 560 055, India. Phone: +91-80-6793 5787

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Index

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Corporate Snapshot - -------------------------------------------------------------------------------------3Course Highlight - -----------------------------------------------------------------------------------------4Course Type ------------------------------------------------------------------------------------------------ 5 Certification - -----------------------------------------------------------------------------------------------6 Course List Executive & Advance Programs - ----------------------------------------------------7Course list Certificate Programs - --------------------------------------------------------------------8 Executive Program in Pharma Global Business ------------------------------------------------9-11Advance Diploma in Pharma Product Management -------------------------------------------12Certificate Course in Pharma Product Management ------------------------------------------12Advance Diploma in Pharma Sales Management - ---------------------------------------------13Advance Diploma in Drug Regulatory Affairs - --------------------------------------------------14-15Certificate Course in Drug Regulatory Affairs - -------------------------------------------------15Advane Diploma in Pharma Marketing ------------------------------------------------------------16Advance Diploma in Pharmacovigilance ---------------------------------------------------------17Certificate Course in Pharmacovigilance --------------------------------------------------------17Advance Diploma in Strategic Management - ---------------------------------------------------18Advance Diploma in Pharmaceutical Production Management - -------------------------19Advance Diploma Dual Specialization - -----------------------------------------------------------20Certificate Course in GMP and GMP Audit ------------------------------------------------------- 21Certificate Course in Drug Registration in ASEAN countries -----------------------------22Certificate Course in Drug Registration & Dossier Preparation - -------------------------23Certificate Course in Drug Development to Commercialization --------------------------24Certificate Course in Intellectual Property Management in Pharmaceuticals --------25Certificate Course in Drug Registration in GCC countries --------------------------------- 26Certificate Course in Quality Assurance & Documentation --------------------------------27Certificate Course in Medical Devices Regulation -------------------------------------------- 27Certificate Course in Biosimilar Regulation -----------------------------------------------------28 Certificate Course in USFDA regulation of Pharmaceuticals, Biotech and medical devices - ----------------------------------------------------------------------------------------29Certificate Course in Clinical Research - ---------------------------------------------------------30Certificate Course in Pharmaceutical Project Management -------------------------------31Testimonial from students ---------------------------------------------------------------------------32Past Performer -------------------------------------------------------------------------------------------33Other Noteworthy Performer ------------------------------------------------------------------------34Frequently asked questions related to the course --------------------------------------------35-36Admission Process ------------------------------------------------------------------------------------37Application form ---------------------------------------------------------------------------------------- 38Sample Certificate --------------------------------------------------------------------------------------39Contac us --------------------------------------------------------------------------------------------------40

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Corporate Snapshot

NCK Pharma Solution Private Limited has created iconic training brand "Knowledge Process Enhancer®" which is approved by International Association of Distance Learning (IADL) registered under the Trademark Registry of India under section 42.

Knowledge Process Enhancer® (KPE) is conceptualized with a vision to spearhead innovation in the field of Pharmaceutical, Biotechnology, Medical Devices learning with the technological advances.

The mission is to provide "Best On the go" training services across those industries to create, develop, train tomorrows leaders. All courses are designed by the industry mentors keeping industry working in mind.

KPE courses can be accessed anytime from anywhere.

OPERATION STARTED : 2009

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NCK Pharma Solution Private Limited is the accredited by International Association of Distance Learning, UK.

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Course Highlights

?All courses are practical orientation. Courses are designed with e-lectures, case studies and job simulation which makes course registrant to learn about how workings take place in pharmaceutical,bio-pharmaceuticals and medical devices industry.

All course registrant upon completion of the enrollment procedure will receive personalized webpage through which one can access e-lectures, case studies, job simulation - modules etc.

Printed / Printable modules will be provided for each course registrant. Incase of admission from India, printed module will be sent to correspondance address. Incase of admission from other than India, e-books will be sent by email to registered email id.

All e-study material contains self assessment computer based test.

Flexible online final examination - Final Examination dates can be blocked

Placement assistance is provided for the Executive Program & Advance Diploma program.

The Internationally Accredited course – Accredited by International Association of Distance Learning (IADL), UK.

Knowledge Process Enhance is also registered under Government of India's Trademark Act under section 42.

E-Modules

Printed / Printable Modules

Self Assessment Modules

Online Final Examination

Placement Assistance

Course Accreditation

Practical orientation

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Course Type, Duration & Eligibility

1 Year Executive Program

Course Eligibility:Graduation (B.Pharma, MBBS, BDS, Bsc, Others) / Post Graduation (M.Pharma, M.Sc, MS, M.Tech, Pharma D, etc.) in any discipline. Third and final Year Students of graduation can apply for the course. 5 Years work experience is madatory for registering into course

1 Year Advance Diploma

1 Year Advance Diploma

Dual Specialization

1 Month Certificate Course

1 Week Certificate Course

3 Days Online workshop

3 Days Online workshop

Course Eligibility:Graduation (B.Pharma, MBBS, BDS, Bsc, Others) / Post Graduation (M.Pharma, M.Sc, MS, M.Tech, Pharma D, etc.) in any discipline. Third and final Year Students of graduation can apply for the course

You can convert the course (after enrolling) into the Fast Track Conversion, where you can write/ take examination immediately on completion of 6 month. Infact you can schedule your examination based on your convenience. Please note for advance diploma program you can not write the final examination within 6 month from date of admission.

Fast Track Completion of Advance Diploma Course

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Final Examination, Grading & Certification

Total certification marks is 200 for all courses

Internal Assessment – 50 Final Examination – 150

Grades:More than 75% – DistinctionMore than 60% – 1st ClassMore than 50% – Pass Class———————————

For certification you need to secure 50% of overall and individually in Internal Assessment and Final Examination.

In case of RE-EXAMINATION grades will not be available. Only PASS grade will be provided.

Pattern of Final Examination -

Online examination. MCQ type and short answer type questions of total 150 marks. Number of questions and marks allocated to each question may vary.

When to register for final examination?

For 1 Month Certificate course – After 28 days you can take the final examination. Up to 40 days from registration you are eligible to take the examination.

For 1 Year Advance Diploma Program – After 11th month i.e 12th month you can take your final examination up to 14th month.

Before 7 days of scheduled date of examination you can register for the final examination date and time.

Result of final examination - Results are sent to registered email id within 2 working days from completuon of the examination.

Certificate will be sent to the registrant within 7-10 working days.

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Executive & Advance Diploma Programs

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Course Code: KPE-C-024

Course Title: KPE’s Advance Diploma in Pharmaceutical Global Business

Course Fees: 45000 Indian Rupees (For Payment from India) / 900 USD (For payment outside India


Course Title: KPE’s Advance Diploma in Pharmaceutical Product Management



Course Title: KPE’s Advance Diploma in Pharmaceutical Sales Management



Course Title: KPE’s Advance Diploma in Drug Regulatory Affairs



Course Title: KPE’s Advance Diploma in Pharmaceutical Marketing



Course Title: KPE’s Advance Diploma in Pharmaccovigilance



Course Title: KPE’s Advance Diploma in Pharmaceutical Strategic Management



Course Title: KPE’s Advance Diploma in Pharmaceutical Production Management



Course Title: KPE’s Advance Diploma in Pharmaceutical Marketing & Regulatory Affairs (Dual Specialization)



Course Title: KPE’s Advance Diploma in Drug Regulatory Affairs & Pharmacovigilance (Dual Specialization)


Course Code: KPE-C-021Course Title: KPE’s Advance Diploma in Pharmaceutical Production Management & Regulatory Affairs (Dual Specialization)


Course Code: KPE-C-023Course Title: KPE’s Advance Diploma in Pharmaceutical Product Management & Regulatory Affairs (Dual Specialization)


1 Year Program

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Certificate Course -

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1 Month Program


Course Title: KPE’s Certificate Course in Drug Registration in ASEAN countries



Course Title: KPE’s Certificate Course in GMP & GMP Audit



Course Title: KPE’s Certificate Course in Drug Registration & Dossier Preparation



Course Title: KPE’s Certificate Course in Drug Development to Commercialization



Course Title: KPE’s Certificate Course in Intellectual Property Management in Pharmaceuticals



Course Title: KPE’s Certificate Course in Drug Registration in GCC countries



Course Title: KPE’s Certificate Course in Quality Assurance & Documentation



Course Title: KPE’s Certificate Course in Medical Devices Regulation






Course Title: KPE’s Certificate Course in USFDA regulation of Pharmaceuticals, Biotech and medical devices



Course Title: KPE’s Certificate Course in Clinical Research



Course Title: KPE’s Certificate Course in Pharmaceutical Project Management



Course Title: KPE’s Certificate Course in Pharmaceutical Product Management



Course Title: KPE’s Certificate Course in Pharmacovigilance



Course Title: KPE’s Certificate Course in Drug Regulatory Affairs


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Course Objective: Executive Program in Pharmaceutical Global Business is conceptualized with vision to enhance competency of middle and middle / top level managers who are working in pharmaceutical, biotech, medical devices and allied industry. This course ideally developed for the working professionals of pharmaceutical industry.

COURSE DESCRIPTION

Unlike other business courses that concentrate narrowly on a particular function or piece of the business—accounting, finance, marketing, production, human resources, or information systems, strategic management is a big picture course. It cuts across the whole spectrum of business and management. The center of attention is the total enterprise–-the pharmaceutical industry and competitive environment in which it operates, its long-term direction and strategy, its resources and competitive capabilities, and its prospects for success. Throughout the course, the spotlight will be trained on the foremost issue in running a business enterprise: “What must managers do, and do well, to make the pharmaceutical company a winner in the game of business?” The answer that emerges, and which becomes the theme of the course, is that good strategy-making and good strategy-execution are the key ingredients of company success and the most reliable signs of good management. The mission of the course is to explore why good strategic management leads to good business performance, to present the basic concepts and tools of strategic analysis, and to drill you in the methods of crafting a well-conceived strategy and executing it competently.You’ll be called on to probe, question, and evaluate all aspects of a company’s external and internal situation. You’ll grapple with sizing up a company’s standing in the marketplace and its ability to go head-to-head with rivals, learn to tell the difference between winning strategies and mediocre strategies, and become more skilled in spotting ways to improve a company’s strategy or its execution.In the midst of all this, another purpose is accomplished: to help you synthesize what you have learned in prior business courses. Dealing with the grand sweep of how to manage all the pieces of a business makes strategic management an integrative, KPE’s Executive Program in Pharmaceutical Global Business course in which you’ll see how the various pieces of the business puzzle fit together and why the different parts of a business need to be managed in strategic harmony for the organization to operate in winning fashion.

• To develop your capacity to think strategically about a company, its present business position, its long-term direction, its resources and competitive capabilities, the caliber of its strategy, and its opportunities for gaining sustainable competitive advantage.

• To build your skills in conducting strategic analysis in a variety of industries and competitive situations and, especially, to provide you with a stronger understanding of the competitive challenges of a global pharmaceutical environment.

• To give you hands-on experience in crafting business strategy, reasoning carefully about strategic options, using what-if analysis to evaluate action alternatives, and making sound strategic decisions.

• To acquaint you with the managerial tasks associated with implementing and executing company strategies, drill you in the range of actions managers can take to promote competent strategy execution, and give you some confidence in being able to function effectively as part of a company’s strategy-implementing team.

• To integrate the knowledge gained in earlier core courses in the business school curriculum, show you how the various pieces of the business puzzle fit together, and demonstrate why the different parts of a business need to be managed in strategic harmony for the organization to operate in winning fashion.

• To develop your powers of managerial judgment, help you learn how to assess business risk, and improve your ability to make sound decisions and achieve effective outcomes.

• To help you become more proficient in using personal computers to do managerial analysis and managerial work.• To make you more conscious about the importance of exemplary ethical principles, sound personal and company values, and socially responsible management practices.

• To help you if you so choose, to develop the ability to write a business plan suitable for submission to funding agencies such as the Small Business Association and Venture Capital Firms or even, perish the thought, Banks.




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Major Modules / Area of Coverage in Pharma Global Business

Module 1: Global Business Environment Top Global companies – Innovator and Generic, Top brands, Top Segments – Growth and Attractiveness. Global Pharma Industry: Detailed Overview. Business AnalysisTop 100 brands micro analysis – Segment attractiveness US Pharmaceutical Market and Regulatory environment

Module 2: Drug Discovery and Development R&D Process & Introduction to drug discovery, Investigational New Drug Application (INDA), New Drug Application (NDA), Basic concept and understanding of the Generic Drug, Abbreviated New Drug Application (ANDA), Generic Drug User Fees Act (GDUFA), Prescription Drug User Fees Act (PDUFA), Handling of orange book, Priority Accelerated Review, Practical Training on INDA and ANDA filing, Promotion Advertisement Regulations (Practical), Biological Licensing Application (BLA), USFDA Warning Letter, Handling of warning letter Generic Drug Marketing Strategies Advance study on Para IV Filing, Evergreening – Patent Life Extension Strategies

Module 3: GMP in Pharmaceutical IndustryG1 Premises & Plant Layout Designing, G2 Sanitation and Hygiene, G3 Equipment Modules, G4 Production Modules, G5 Documentation, G6 Quality Control, G7 Product Complaint, G8 Storage Module Handling of Internal Audit, QA detailed Study Pharmaceutical SOPs Management from regulatory perspective SOP Automation in Pharmaceutical Industry Formulation, Quality and Regulatory Manual for handling CAPA Introduction to CAPA, Root cause analysis and handling of deviations, Regulatory plant audit handling and liaising with the regulatory department

Module 4 Certification Pharmaceutical Companies / Plants – Certification in Pharmaceutical CompaniesAnalysis of Certification of leading global pharmaceutical companies (Interactive Case study) ISO and ISO Audits

Module 5 Intellectual Property Right IPR – Introduction, Patent, Patent – Practical on search and filing, Trademark – Practical on TM Search & Registration Process, how to search and register brands in USPTO, Trademark – Practical on TM Search, Trademark Search assignment, 100 of cases demonstratining innovation management in pharmaceutical industry, Practical case studies on IP Management, Technology Transfer in Pharmaceutical Industry

Module 6: International Trade – Basics to advance learning International marketing: Basis of international trade, theories of international trade, Adam Smith, Ricardo. Difference between domestic and international marketing, EPRG framework. Scanning of international environment: Social, political, legal, economic, cultural environment for overseas markets; Factors affecting international trade: Methods of entry, WTO/GATT, regional agreements commodity agreements. Product: Identifying new products, international product planning, product design strategy, product elimination, adoption and diffusion of new products, branding strategies. Pricing strategies: Methods of pricing, pricing an international product, transfer pricing, exchange rates and its impact on pricing factors affecting international prices, dumping and anti-dumping regulations. Distribution strategies: Direct and indirect channels, factors affecting international channels, international channel management. Promotion strategy in overseas markets: Perspectives of international advertising, standardization v/s localization, global media decisions, global advertising regulations, industry self-regulation. Export documentation and procedures. Foreign trade policy: EXIM Policy.

Module 7 Export Documentation – Registration of the pharmaceutical products Introduction to Common Technical Document (CTD), Asean Common Technical Document (ACTD), Advance Practical Training on Dossier Preparation focusing on drug registration in export countries, Assignment and real life dossier preparation – step by step guideline, Overall understanding of dossier compilation process, Modules on Stability Study, Test on Stability Test, Module on Interchangeability, Stability Testing of API, Stability Testing of Finished Pharmaceutical Products, Review Test on Stability Testing, Advance Practical Training on Export Documentation E-CTD – Practical Training on ECTD Regulatory Strategies in different phases of Clinical Trial Packaging Development from Regulatory Perspective Packaging Development, Prescribing Information and Patient Information Leaflet development.

Module 8 DMF & SMF Drug Master File, Site Master File, Practical Training on preparing DMF and SMF

Module 9: Advance understanding on Biosimilar Drugs and Guidelines Introduction to Biosimilar, Biosimilar Approval process, Global Biosimilar Marketing Strategies.



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Major Modules / Area of Coverage in Pharma Global Business

Module 10: Project Management skills for regulatory professionals Introduction to Pharma Project Management – PERT, CPM, Critical Path, Project Diagram and its components, Basics of Project Management, Importance of Project Manager in Pharma Industry , Milestone and Cycle Time Development in Project, Project Termination and Project initiation in Pharmaceutical Industry, Project Control and importance of Asset Tracking as an adjunct to Project Tracking, Levels of the Project Management, Combining Portfolios From Mergers & Acquisitions in Bio/pharmaceutical R&D

Module 11: Portfolio Management Advance understanding of the portfolio Management , Importance of market research in pharmaceutical industry, Co-promotion & Co-marketing strategy in pharma industry, Concept of Reverse co-promotion in pharma industry, In-Licensing Vs. Outlicensing, Importance of Publications in Pharmaceutical Industry, New Indication Approval Process and Promotion, OTC Switch

Module 12: ASEAN Country Analysis – Pharmaceutical Business and Regulatory Business Environment Analysis ASEAN Drug Regulatory Affairs, Asean Geography, Drug Registration in Brunei, Drug Registration in Malaysia, Drug Registration in Cambodia, Drug Registration in Mayanmar, Drug Registration in Philippines, Drug Registration in Singapore, Drug Registration in Vietnam, Drug Registration in Laos, Drug Registration in Indonesia, Drug Registration in Yemen, Drug Registration in Saudi Arabia, Drug Registration in Beherain, Drug Registration in Kuwait, Drug Registration in Qatar, Drug Registration in UAE

Module 13: CDSCO – Drug Regulation in India India – Pharmaceutical Business Environment, Drug Regulation in India – CDSCO, National Pharmaceutical Pricing Authority, Drug Price Regulation in India, Drug Registration in India – Practical, understanding drug registration process in CDSCO, Drug Price Control Order 2013

Module 14: Pharmaceutical Business Anslysis in European Country Centralized Procedure, Decentralized Procedure, Mutual Recognition Procedure, Dossier Preparation for European submission

Module 15 Strategy, Strategic Management Process Levels of Strategies- Corporate, Business and Operational level, Types of Strategies- Functional Strategies, H. R Strategy, Marketing strategy, Financial Strategy, Operational StrategyIntroduction to Corporate Restructuring, Need for corporate restructuring and forms of corporate restructuringStrategic Deals Merger, acquisition. Outsourcing Concept of Outsourcing in pharma business, Strategic Reasons of growing Outsourcing in pharmaceutical BusinessCorporate Positioning and Repositioning exercise

Module 16 : Pharmaceutical Brand Management Module

17: Basics of Operation Management Module 18 Top Global Pharma companies – Portfoilo and business focus analysis Case Study on Strategic Analysis / deals on global pharmaceutical industry

Module 19 Online Promotion Strategies

Introduction to SEO, Online B2B promotion, Developing, executing online business promotion techniques.

Live simulation

Module 20 African Drug Market – Strategic Analysis – african Country specific analysis

Module 21 Finance for strategic management professionals

Capstone Simulation –

Case based approach. The focus of this course is on managing a “real “company that is competing in a “real” industry. You will be part of a management team, which will be in charge of a specific company. You need top analyze the external,



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Course Objective: Advance Diploma in Product Management is conceptualized with vision to create effective Product Manager for Pharma Industry. This course gives practical knowledge / real life job simulation for Pharma Product Management.

This course gives practical knowledge / real life job simulation for Pharma Product Management.How product manager works in pharma company.

The Pharmaceutical Market - Overview of Pharmaceutical industr, Evolution of Indian pharmaceutical Industry, Current domestic and global market, Prescription vs. OTC market, Major stakeholders in domestic and global market, Regulatory environment in pharmaceutical industry

Understanding of Pharmaceutical Marketing - What is marketing? (Brief understanding and Definitions), Significance of marketing in pharmaceutical business, Customer vs. consumer, Pharmaceutical market vs. consumer market, Basic elements of Marketing Mix (4 P’s), Pharmaceutical product management

Practical aspects of pharmaceutical brand management - What is brand management, Product management team, Product management vs. sales, Hierarchy in pharmaceutical marketing, Product management vs. Sales hierarchy, Importance brand management in pharma, Role of product manager/brand manager, Product management process

Development of marketing plan - Marketing plan - Understanding of marketing plan, Components of marketing, Market research, Objectives of market research, Importance of pharma market research, Common types of pharmaceutical market research, Industry or Market segment research, Prescriber’s (Doctors) research, Consumer research (Patients), Competitors’ research, Situational Analysis - SWOT analysis, PEST Analysis, GAP analysis, Porter’s five force analysis, Marketing strategy, Strategy vs. Tactics, Strategic and tactical planning, Case study: Strategic and tactical planning

Pharmaceutical market segmentation - Understanding of market segmentation, Types of segmentation, Bases for pharmaceutical market segmentation, Importance of segmentation, Case study: Market Segmentation

Targeting & Positioning - Targeting, Understanding of targeting, Bases for targeting in pharmaceutical market, Positioning - Understanding and positioning, Bases for positioning in pharmaceutical market, Case Study: Targeting and Positioning

Branding - Understanding of branding, Importance of branding in Pharma, Branding Strategies, Process of brand name selection, Brand name and Logo, Punch line / tagline creation for brand, Positioning statements & Unique Selling Propositions (USPs), Case study: Branding, Product Strategies

Understanding of product concept - Product briefing, Product differentiation, Product differentiation tools, Product mix and product lines, Role of product innovation in pharma, New product development process, Product lifecycle and portfolio management, Price strategies

Understanding of pricing in pharma industry - Objectives of pricing, Bases for pricing, Pricing strategy, Pricing process in pharma, Case study: Pricing

Distribution strategies - Understanding of distribution channel, Importance in pharma industry, Intermediaries in pharma distribution channel, Super distributor, C & F agents, Stockiest or Distributor, Retailer, Levels of Distribution in pharma industry - Case study: Distribution

Marketing communication Strategies (Promotional strategies) - Understanding of marketing communication process, Objectives of marketing communication, Customer vs. consumer concept in pharma, Consumer behaviour in pharma, Factors affecting doctor’s prescribing decision

Promotional campaign development - Understanding of promotional campaign, Objectives of campaign, Promotional inputs in pharma, Objectives of Promotional inputsVisual Aids creation and detailing story writing, Objectives, Process of VA creation, How to write detailing story, Case study: VA creationE-detailingLeave behind literatures (LBLs) - Objectives, Process of LBLs creation, Case study: LBLs creationReminder cards (RC) - Objectives, Process of RC Creation, Case study: RC creationCatch covers - Objectives, Process of Catch covers creation, Case study: Catch covers creationPromotional items selection - Objectives, Process of Promotional items selection, Case study: Promotional item selectionPrinting of promotional literatures - Vendor selection, Paper selection, Types of paper availablePromotional Budgeting - Objectives of budget planning, Methods promotional budgetingTraining of sales person - Objectives of sales training, Types of training sales methods, Training manual creation, Case study: Training manual creationCareer prospects in pharmaceutical product management


Course Title: KPE’s Advance Diploma in Pharmaceutical Product Management


Also available 1 Month Certificate Course in Pharma Product Management.


Course Title: KPE’s Certificate Course in Pharmaceutical Product Management


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Course Objective: Advance Diploma in Sales Management is conceptualized with vision to create effective Sales Professionals for Pharma Industry. This course gives practical knowledge of the functionalities of sales Manager with practical exposure.

Major Modules:

Overview of Pharmaceutical Industry – Market Size, Valuation, Top Players, Leading segments, Classification / Segmenting Pharmaceutical Market, Leading brands.

Overview of Drug Discovery to commercialization Process. A brief understanding to Generic Market

Introduction to Pharma Sales – Importance, Job and key responsibilities of pharma sales professionals.

Hierarchy of pharma sales department – Designations and their responsibilities.

Medical Representative – Evergreen Profession. Career focus and growth path. Detailed and practical study and analysis of the medical representatives job profile with real life case studies.

Roles & Responsibilities of 1st Line Manager (Area Sales Manager) – Planning, Directing and Controlling etc., Evaluation of the Sales Force – on the job and off the job assessment, Sales Routine in Joint Field Work by ASM.

Roles & Responsibilities of 2nd Line Manager (Regional Sales Manager)

Brief overview of pharmaceutical marketing – Definitions, related terminologies.

Managing Market & Sales Information – Introduction, Market Survey – RCPA (Retail Chemist Prescription Audit), Analysis of Information from Market Survey, Identifying the customer needs. Action plans on outcome of the market research, designing and managing services in Pharmaceutical Marketing.

Case Study based understanding on differentiating pharma sales with allied product selling – Difference between FMCG and Pharma Selling, Difference between Surgical Product and Pharma Product selling, medical devices selling and pharma selling

Selling skills – Introduction. Product knowledge, territory management skills and attitude.

Management of Sales Territory & Sales Target – Introduction to management of sales territory and sales target, Sales Promotional Inputs, Designing and allocation of sales territory and sales target.

Competitor Knowledge – Introduction, Ways of gathering information for Market Research, Implication of Market Analysis, Checklist for market analysis. Competitor analysis.

Pharma Sales Tools – Visual aid, Leave Behind Literature, Catch Cover, Physician Samples, Reminder Card etc.

Sales Planning & Forecasting Process – Importance, case based analysis.

Emerging Trend in Sales Management – Introduction, Field Monitor Control and the Sales Promotion Linkage – Concept, Tools Available, and Persons Responsible and Self-Monitoring.

Sales Analysis – Skill – Collection of Data, Assessment of Historical Data, Trend Analysis and Projection, Identifying Problems in allocation of Sales Territories and Sales Target.

Sales Reporting – Representative Reporting – Daily Call Report, Tour Program, Doctor List, Expense statement, Standard Fare Chart.

Sales Target – Organizing the Sales Territory to Accomplish Sales Target. Different methods of fixation of target.

Sales Incentive – Performance based incentivizing the sales. Incentive – How to design and how.

Importance of Branding in Pharma Selling- Brand Positioning – Definition, Positioning Strategies, Segmentation, Positioning Difference, Why positioning is key to achieve sales mission.

Launching of a new product – Pre-launch of a new product, Project Evaluation and Review Technique, Tips for launching a new product, Launch of a new product (Post Launch), The specific goals of Feedback.

Key Opinion Leader (KOL) Management in pharma sales – Introduction, Importance and skills / know how for effective management of Key Opinion Leaders.

Preparing Sales Presentation – Case based analysis


Course Title: KPE’s Advance Diploma in Pharmaceutical Sales Management


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Course Objectives:

Pharmaceutical Regulatory Affairs courses are conceptualized with vision to create effective Regulatory Affairs Manager for Pharma Industry. This course gives practical knowledge of the functionalities of Regulatory Manager with practical exposure.

Career in Drug Regulatory Affairs

A career in Regulatory Affairs is both a challenging and highly rewarding career. It opens up lot of opportunities as it covers a variety of disciplines. Individuals who are directly involved in regulatory submission, compliance, clinical trials, quality assurance, drug safety, pharmacovigilance and others are considered regulatory professionals.

The Pharma industry is growing at a rapid pace and there is a rising concern over the safety and efficacy of pharmaceutical and medical device products. To maintain safety and efficacy in pharma & medical device products, regulatory agencies like US FDA,UK MHRA, EDQM, DCGI etc all over the world are imposing no of regulation. This has resulted in creation of distinct department with highly qualified professionals who will help companies meet these requirements with ease.

Major Modules

Phase 1 Drug Regulation FundamentalsR&D Process & Introduction to drug discoveryInvestigational New Drug Application (INDA)New Drug Application (NDA) Basic concept and understanding of the Generic DrugDRA working in DRA departmentAbbreviated New Drug Application (ANDA)Generic Drug User Fees Act (GDUFA)Prescription Drug User Fees Act (PDUFA)Handling of orange bookPriority Accelerated ReviewPractical Training on INDA and ANDA filingPromotion Advertisement Regulations (Practical)

Phase 2 Certification Pharmaceutical Companies / PlantsCertification in Pharmaceutical Companies

Phase 3 ISO and ISO Audits

Phase 4 GMP in Pharmaceutical IndustryIntroduction to Good Manufacturing PracticesShort Test on GMPG1 Lecture Premises & Plant Layout DesigningG2 Lecture Sanitation and HygieneG3 Lecture Equipment ModulesG4 Lecture Production ModulesG5 Lecture DocumentationG6 Lecture Quality ControlG7 Lecture Product ComplaintG8 Lecture Storage Module

Phase 5 Intellectual Property RightIPR – IntroductionPatent \Patent – Practical on search and filingTrademark – Practical on TM Search & registration ProcessTrademark – Practical on TM SearchTrademark Search assignment

Phase 6 Dossier ReparationIntroduction to Common Technical Document (CTD)Asean Common Technical Document (ACTD)Advance Practical Training on Dossier Preparation focusing on drug registration in export countriesAssignment and real life dossier preparation – step by step guidelineOverall understanding of dossier compilation processModules on Stability StudyTest on Stability TestModule on Interchangeability

Stability Testing of APIStability Testing of Finished Pharmaceutical Products

Review Test on Stability Testing

Phase 7 Registration of the Drug Products in the overseas marketPractical Training on Export Documentation

Phase 8: Drug Regulatory Review (48 Chapters with case studies)

Phase 9 E-CTD

Phase 10 Regulatory Strategies in different phases of Clinical Trial




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Phase 11 Packaging Development from Regulatory PerspectivePackaging DevelopmentPrescribing Information and Patient Information Leaflet developmentPhase 12 DMF & SMFDrug Master FileSite Master FilePractical Training on preparing DMF and SMF

Phase 13 Generic Drug Marketing StrategiesAdvance study on Para IV FilingEvergreening – Patent Life Extension Strategies

Phase 14 ASEAN DRAASEAN Drug Regulatory AffairsAsean GeographyDrug Registration in BruneiDrug Registration in MalaysiaDrug Registration in CambodiaDrug Registration in MayanmarDrug Registration in PhilippinesDrug Registration in SingaporeDrug Registration in VietnamDrug Registration in LaosDrug Registration in Indonesia

Phase 15 Advance understanding on Biosimilar Drugs and GuidelinesIntroduction to BiosimilarBiosimilar Approval process

Phase 16:Biological Licensing Application (BLA)Vaccine development and approval Process

Phase 17 API Regulatory Affairs

Phase 18USFDA Warning LetterHandling of warning letter

Phase 19Technology Transfer in Pharmaceutical Industry

Phase 20Handling of Internal AuditQA detailed Study

Phase 21 SOP Management for better effectiveness of plantPharmaceutical SOPs Management from regulatory perspectiveSOP Automation in Pharmaceutical Industry

Phase 21 Formulation, Quality and Regulatory Manual for handling CAPAIntroduction to CAPARoot cause analysis and handling of deviationsRegulatory plant audit handling and liaising with the regulatory department

Phase 22Global Pharma IndustryIndian Pharma Industry

Phase 2348 different topics of the Regulatory Affairs, Case Studies and Self Assessment TestsPhase 24 CDSCO – Drug Regulation in India

Phase 24 Drug Regulation in India – CDSCONational Pharmaceutical Pricing AuthorityDrug Price Regulation in IndiaDrug Registration in India – Practical understanding drug registration process in CDSCODrug Price Control Order 2013

Phase 25 Drug Registration in GCC countries

Drug Registration in Saudi ArabiaDrug Registration in BeherainDrug Registration in KuwaitDrug Registration in QatarDrug Registration in UAE

Phase 26 Project Management skills for regulatory professionalsIntroduction to Pharma Project Management – PERT, CPM, Critical Path, Project Diagram and its componentsBasics of Project ManagementImportance of Project Manager in Pharma IndustryMilestone and Cycle Time Development in ProjectProject Termination and Project initiation in Pharmaceutical IndustryProject Control and importance of Asset Tracking as an adjunct to Project TrackingLevels of the Project ManagementCombining Portfolios From Mergers & Acquisitions in Bio/pharmaceutical R&D

Phase 27 Portfolio ManagementAdvance understanding of the portfolio ManagementImportance of market research in pharmaceutical industryCo-promotion & Co-marketing strategy in pharma industryConcept of Reverse co-promotion in pharma industryIn-Licensing Vs. OutlicensingImportance of Publications in Pharmaceutical IndustryJuxtapid Case StudyNew Indication Approval Process and PromotionOTC Switch

Phase 28 Drug Registration in European CountryCentralized ProcedureDecentralized ProcedureMutual Recognition ProcedureDossier Preparation for European submission




13Course Code: KPE-C-046

Course Title: KPE’s Certificate Course in Drug Regulatory Affairs

Also available 1 Month Certificate Course in Drug Regulatory Affairs.


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Course Objective: Advance Diploma in Pharmaceutical Marketing is conceptualized with vision to create effective Marketing / Business Devleopment Manager for Pharma Industry. This course gives practical knowledge of the functionalities of Pharma Manager with practical exposure.

Major Modules:

Marketing Syllabus:

1. Basics of Marketing: What is marketing? Why business needs marketing orientation? 4 P’s of Marketing. Marketing Environment & competitor analysis – SWOT & PEST. Factors affecting Marketing. Market orientated strategic planning. Competition & Competitors. Targeting, Segmentation & Positioning. Developing competitive differentiation.

2. Product- Introduction, Basic concepts of product, Product Differentiartion, Differentiation tools, Product Classification, Product Mix & Product Lines, Brand Decisions Product Development Process. Product Life Cycle & Product Life Cycle Management

3. Price- Definition, History of Price Control in Indian Pharmaceutical Market, Price in Marketing Mix? Basis for pricing, Pricing strategies, Pricing management.

4. Distribution – Basics of distribution in Indian Pharmaceutical market, Pharmaceutical Distribution Channels, single channel v/s multiple channel strategies , AIOCD, NOC & LOC, Physical distribution, Role & Responsibilities of chemist.

5. Marketing Research – Introduction: Nature, scope and importance of marketing research, role of marketing research in decision marking; Factors influencing marketing research decisions, marketing information systems, the marketing research process., Problem identification, Research design: Exploratory, descriptive and conclusive. Methods of data collection – observation, experimentation, survey, desk research method, Sampling Plan: Sampling method, sample size, designing of questionnaire, Field investigation., Data processing: Editing, coding, classification and tabulation, Data analysis: Hypothesis testing., Application: Product research, advertising research, market and sales analysis research.

6. Promotion – Integrated Marketing Mix – Introduction, objective, Communication Mix, Basics of Marketing communication, Marketing Communication Process, Factors affecting communication mix, Media Mix, Developing a communication campaign, Budegeting for marketing communication Issues in pharma product promotion, approaches for pharma product promotion, DTC, e-detailing, physician related promotional programmes for increasing acceptance and sales of pharma products.

7. Pharmaceutical Brand Management- Branding and its potential within the pharmaceutical industry: History, meaning, need, importance, branding in pharmaceutical industry, building brand values and brand strategy, timing, patient power, strategic brand management process. The role of advertising in branding pharmaceuticals. PMT – Job Responsibility, Hierarchy of marketing team, Career prospect in PMT, Product Management Process, Preparing a brand plan, Product Strategy, Tools of pharmaceutical promotion – Visual Aid, Leave Behind Literature (LBL), Technical Folder designing. Marketing campaign preparation – how to design marketing campaign, writing a marketing campaign, Implementation of campaign (on field & off field activity of PMT), Monitoring of campaign success. Detailing – Detailing for brand positioning, detailing talk preparation and Ideal detailing talk. Handling and usage of visual Aid.

8. Strategy – Brand Strategy, Types of strategy with case study, Strategy for new product launch – Forecasting, Technical, Budgeting, market plan. Co-promotion. Case Study

9. International Marketing – International marketing: Basis of international trade, theories of international trade, Adam Smith, Ricardo. Difference between domestic and international marketing, EPRG framework. Scanning of international environment: Social, political, legal, economic, cultural environment for overseas markets; Factors affecting international trade: Methods of entry, WTO/GATT, regional agreements commodity agreements. Product: Identifying new products, international product planning, product design strategy, product elimination, adoption and diffusion of new products, branding strategies. Pricing strategies: Methods of pricing, pricing an international product, transfer pricing, exchange rates and its impact on pricing factors affecting international prices, dumping and anti-dumping regulations. Distribution strategies: Direct and indirect channels, factors affecting international channels, international channel management. Promotion strategy in overseas markets: Perspectives of international advertising, standardization v/s localization, global media decisions, global advertising regulations, industry self-regulation. Export documentation and procedures. Foreign trade policy: EXIM Policy.

10. Drug Development & Lifecycle Management Strategies:

New Drug Development Strategies, Lifecycle Management Strategies, Generic Drug Development and Management Strategies, Blockbuster Drug Management Strategies, Clinical Trial for Lifecycle Management, Licensing for Growth – In Licensing Vs. Out Licensing

11. Pharmaceutical Business Model


Course Title: KPE’s Advance Diploma in Pharmaceutical Marketing


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Course Title: KPE’s Advance Diploma in Pharmacovigilance

Course Objective: Advance / PG Diploma in Pharmacovigilance is conceptualized with vision to create effective Pharmacovigilance for Pharma Industry. This course gives practical knowledge of the functionalities of Pharmacovigilance with practical exposure. The prime objective is to provide a high-end training thereby enhancing the employment prospects of the participants.

The Pharmacovigilance & Drug Safety course gives you a good understanding of the basic principles of pharmacovigilance – the course covers the history of pharmacovigilance & drug safety, key components within adverse event reporting in the clinical and post-marketing settings and an overview of signal detection & risk management.

Keeping products on the market without interruption becomes more essential with the reduced pipeline of drugs in development. Successful navigation of drug safety and pharmacovigilance are keys to product longevity, consumer confidence and regulatory compliance. This module will provide you with a strong foundation of knowledge on pharmacovigilance and drug safety.

Content

The course has been designed and tailored specifically to the needs of research industry.

• Introduction to Clinical Research and Pharmacovigilance

• Global Pharmacovigilance System

• Sources and Documentation of Individual Case Safety Reports (ICSRs)

• Case processing and Reporting

• Medical dictionary (MedDRA) and Medical aspects in Pharmacovigilance

• Special cases in Pharmacovigilance

• Medical Information System

• Safety monitoring in Clinical Trials

• Signal detection

• Periodic Safety Update Reports (PSURs)

• Risk –benefit assessment and management in Pharmacovigilance

• Standard operating procedures in Pharmacovigilance

• Compliance monitoring and Pharmacovigilance inspections

• Global regulatory requirements and guidelines in Pharmacovigilance

• Pharmacovigilance communications

• Pharmacoepidemiology


Course Title: KPE’s Advance Diploma in Pharmaccovigilance



Course Title: KPE’s Certificate Course in Pharmacovigilance


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Course Objective: The objective of this course is to impart knowledge and understanding of the Pharmaceutical Strategic Business Management from the 360 degree from the different areas of Pharmaceutical Management.

Key Learning Area for the course

Drug Development to Commercialization Innovation Management Marketing Strategic Planning Generic Drug Strategic Planning Production Planning and Strategic Management Managing SBU revenue model Drug Registration overseas International Marketing strategic planning Licensing – In Licensing Vs. Out licensing Business Audit Human Resource strategic planning QA/QC Team – Differentiator of Today’s Manufacturing organization Financial Planning and Management Accreditation Management and PR strategies Web strategies for Pharmaceutical companies

Syllabus:

Drug Development & Lifecycle Management Strategies:New Drug Development StrategiesLifecycle Management StrategiesGeneric Drug Development and Management StrategiesBlockbuster Drug Management StrategiesClinical Trial for Lifecycle ManagementLicensing for Growth – In Licensing Vs. Out Licensing

Pharmaceutical Production Strategic PlanningOptimizing Pharmaceutical Production ProcessProduction Forecasting and Planning – Batch ProductionC-GMP Implementation and handling auditsStrategic Understanding of Inventory ManagementSoftware’s for Pharmaceutical ManufacturingSOP Management, Validation Protocol and BMR

Strategic Planning for Pharmaceutical MarketingPharmaceutical Marketing Strategic PlanningProduct Differentiation StrategiesPricing StrategiesDistribution strategiesPromotion strategies

Pharmaceutical Business Model

Product Development > Manufacturing > MarketingProduct Development > Manufacturing > LicensingManufacturing > Marketing3rd Party Manufacturing > MarketingMarketing

International Marketing Strategic PlanningDrug Registration for International MarketingDrug Dossier Preparation – CTD, ECTDDrug Registration in IndiaDrug Registration in ASEAN countries (ACTD)Drug Registration in USADrug Registration in EUPolicies for International Marketing

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Course Title: KPE’s Advance Diploma in Pharmaceutical Strategic Management


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Course Objective: Advance Diploma in Production Management is conceptualized with vision to create effective Production Manager for specifically for handling pharmaceutical formulation plant. This course gives practical knowledge of the functionalities of production related jobs / decision making skills.

Careers in Pharmaceutical Production Management:

Industrial production management is concerned with the organization of raw material, machinery and labour to produce the desired goods or services along with taking care of quality and quantity of the products so produced. Industrial production managers are responsible for production schedule and staffing, procurement and maintenance of equipment, quality control and coordination of production activities among different departments. While controlling the overall production process they also take care of economic efficiency and in-time delivery of the goods and services so produced. Besides, they should be aware of the recent market trends and the resultant change in the demand pattern. Also Production Manager should able to handle the export requirement, therefore working knowledge of the Regulatory Affairs (e.g dossier preparation, DMF, GMP norms) are of importance.

Opportunity Area:

With strengthening of domestic and international regulatory standards, new drug discovery & formulation development, quality requirements as well strengthening of the marketing approval of pharmaceutical products, there is high demand in pharmaceutical industry for qualified and well knowledge production managers in production department of the company.

Large pool of manufacturers, high competition and strict regulation on quality of medicine compelled manufacturers to hire skilled, qualified, and well knowledgable production managers to maintain high productivity, economies of scale as well as quality standards to survive in the industry.

This course will give a huge value addition to your professional career. As production manager, you must be knowing important aspects of regulatory affairs including, GMP, GCP, ISO as well as Handling of Audit, standards of international regulations like ICH, USFDA, CDSCO etc.

This course is designed by industry experts to simulate practical knowledge & skill required by industry with minimal course fees. You will be getting Practical Knowledge of Pharmaceutical Production similarly as Industry require.

Syllabus:

PILOT PLANT AND SCALE-UP TECHNIQUES – Pharmaceutical Pilot plant – Pilot plant design – Case studies for tablets – Capsules – Aerosols – Liquid orals – Parenterals – Sustained release preparation – Semi-solid preparation – Basic requirements – Design of product – Facility – Equipment selectionand personnel.

PRODUCTION, PLANNING, SCHEDULING AND FORECASTINGProduction systems – Production department – Production process routing and loading –Scheduling – Despatching of records – Production control.FORMULATION PRODUCTION MANAGEMENT – Plant site selection and layout – Material handling for various pharmaceutical products – Service facilities – Preventive maintenance in pharmaceutical companies – Group andindividual replacement.MATERIAL MANAGEMENT- Materials – Quality and quantity – Value analysis – Purchasing – Centralized and decentralized – Vendor development – Buying techniques – Purchasing cycle and procedures – Stores management – Salvaging and disposal of scrap surplus – Selective inventory control – RQM and EOQ – Modern inventory management systems – Cost and savings in inventory.HUMAN RESOURCE DEVELOPMENT – Human resource planning – Job analysis and design – Recruitment – Personnel selection – Orientation and placement – Training and development – Supervision – Performance appraisal – Remuneration and salaries – Compensation – Industrial relations – Motivation – Labour welfare.Real life exposure to SOP management system with 400 real life SOPs operating in pharma industry.GMP and GMP documentations and handling of GMP audit .Detailed study on the Drug Regulatory Affairs with exposure to drug registration in different countries.Pharmaceutical Formulation and Manufacturing Project Management skill trainingSpecial module on setting up of the pharmaceutical production plant

Basic Training on Drug Regulatory affairs and training on drug dossier preparation.

Special module on export documentation.


Course Title: KPE’s Advance Diploma in Pharmaceutical Production Management


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Course Title: KPE’s Advance Diploma in Pharmaceutical Marketing & Regulatory Affairs (Dual Specialization)

This course is designed to provide the comprehensive understanding of Drug Regulatory Affairs and Pharmaceutical Marketing.

Syllabus - Advance Diploma of Pharmaceutical Marketing & Advance Diploma in Drug Regulatory Affairs separately. All modules of both advance diploma program is covered in single course.


Course Title: KPE’s Advance Diploma in Pharmaceutical Product Management & Regulatory Affairs (Dual Specialization)

This course is designed to provide the comprehensive understanding of Drug Regulatory Affairs and Pharmaceutical Product Management.

Syllabus - Advance Diploma of Pharmaceutical Product Management & Advance Diploma in Drug Regulatory Affairs separately. All modules of both advance diploma program is covered in single course.

Course Code: KPE-C-021Course Title: KPE’s Advance Diploma in Pharmaceutical Production Management & Regulatory Affairs (Dual Specialization)

This course is designed to provide the comprehensive understanding of Drug Regulatory Affairs and Pharmaceutical Production Management

Syllabus - Advance Diploma of Pharmaceutical Production Management & Advance Diploma in Drug Regulatory Affairs separately. All modules of both advance diploma program is covered in single course.


Course Title: KPE’s Advance Diploma in Drug Regulatory Affairs & Pharmacovigilance (Dual Specialization)

This course is designed to provide the comprehensive understanding of Drug Regulatory Affairs and Pharmacovigilance

Syllabus - Advance Diploma of Advance Diploma in Drug Regulatory Affairs & Pharmacovigilance separately. All modules of both advance diploma program is covered in single course.





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Course Objective: The objective of this course is to impart knowledge and understanding GMP, C-GMP requirement of the pharmaceutical manufacturing plant and managing audit procedure to maintain the same.

This online GMP training course utilizes interactive learning tools to guide each participant through the steps of the drug development process. The course is designed to challenge students to apply what they have learned through the use of interactive exercises, reflection questions, expert live chat and a final assessment at the end of the course.

The GMP course can be completed at any pace, allowing the user to stop and start at their leisure.

This course is divided into following modules

1. Quality : definition, evolution, attributes, concept and specific aspects for pharmaceutical products

2. GMP and its relationship with quality basics to specifics, History of GMP and its evolution and progress,

Progress of GMP with current status regulatory status and trends of various regulatory agencies with important milestones

3. GMP regulations and standards

4. Requirements, scope, objective and principles and practices of GMP with emphasis on GMP requirements of WHO ,TGA, MHRA, MCC, HPFBI, PICS, EU, ICH, USFDA and the new Schedule M.

5. Obtaining International GMP Certification and maintaining the GMP continuum.

6. Principles of Quality Assurance and Quality management Systems

Principles and Practices of Good Laboratory Practices,

7. Good Documentation Practices, water systems, stability studies,

8. Advances in GMP, Training and Auditing in GMP, Handling international GMP audits effectively and successfully,

Implementing GMPs in your organization, and getting the most out of quality by maintaining the GMP continuum.


Course Title: KPE’s Certificate Course in GMP & GMP Audit


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This online course utilizes interactive learning tools to guide each participant through the steps of drug regulation and registration process for the ASEAN countries. The course is designed to challenge students to apply what they have learned through the use of interactive exercises, reflection questions, expert live chat and a final assessment at the end of the course.

The course can be completed at any pace, allowing the user to stop and start at their leisure.

Course Title: KPE’s Certificate Program in Drug Registration in ASEAN Countries

Course Objective: The objective of this course is to impart knowledge and understanding OF Drug Registration Procedure in ASEAN countries – Regulations, Registration procedure, Country specific Common Technical Document, ACTD guidelines and dossier preparation.


1. Overview of the ASEAN countries : Country Introduction

2. Introduction to Drug Regulation and Registration Process of the each countries

3. Introduction to ASEAN Common Technical Document

4. Comparison Study of ACTD, ICH CTD and e-CTD.

5. Obtaining International GMP Certification and maintaining the GMP continuum.

6. Drug Dossier Preparation : Interactive Session

7. Drug Registration Process – Time Line (country specific)

8. Registration of Innovative Pharmaceutical Products in ASEAN countries


Course Title: KPE’s Certificate Course in Drug Registration in ASEAN countries


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Course Title: KPE’s Certificate Program in Drug Registration and Dossier Preparations.

Course Objective: The objective of this course is to impart knowledge and understanding of Drug Registration and Dossier Preparation.

Course Description

This online course utilizes interactive learning tools to guide each participant through the steps of drug regulation and registration process for different regulatory bodies and practical exposure in drug dossier preparation. The course is designed to challenge students to apply what they have learned through the use of interactive exercises, reflection questions, expert live chat and a final assessment at the end of the course.



1. Overview of the Drug Regulation and different regulatory bodies. Basic in-depth Training on regulatory affairs.

2. Drug Registration Process.

3. Drug Dossier and its components.

4. Page by page development of Drug Dossier Preparation.

Detailed page by page CTD preparation included. Course will also provide open file of 154 Page real life CTD (dossier).


Course Title: KPE’s Certificate Course in Drug Registration & Dossier Preparation


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Course Description

This online drug development training course utilizes interactive learning tools to guide each participant through the steps of the drug development process. The course is designed to challenge students to apply what they have learned through the use of interactive exercises, reflection questions, expert live chat and a final assessment at the end of the course.


Course Title: KPE’s Certificate Program in Drug Development Process: Discovery to Commercialization

Course Objective: The objective of this course is to impart knowledge and understanding of the Drug Development Process – from discovery to commercialization – different strategic planning involved in the different phases.

Syllabus:

The online drug development process course is broken down into four modules:

The Drug Development Process Regulatory Environment – It also offers a perspective into global regulatory entities, as each country is equipped with its own laws, regulations and guidelines.

Stages in the Drug Development Process – the second module provides a detailed overview of the drug development process, taking a look at the life cycle, history, timelines and phases critical to the process. The module covers the product discovery and clinical testing steps essential to the early stages of the drug development process. This is followed by the activities needed for regulatory approval, manufacturing scale-up and post-market issues such as adverse event monitoring/reporting and patent exclusivity.

Pre-Clinical Steps in Drug Development – the third module is centered on the pre-clinical studies used to see if a product is reasonably safe for animal subjects and later for human testing. Subjects include pre-clinical pharmacology, pharmacokinetics, GLP compliance and more.

Clinical Steps in Drug Development -This covers what happens after discovering an NCE, conducting pre-clinical trials and completing the IND/CTA application. Attendees will learn the different phases of these clinical studies and about the NDA/MAA application.

Launching and marketing of Innovative Branded Drug – marketing planning, strategic initiative, usage of clinical trial in marketing, Product Life cycle Management, forward and backward integration for the branded pharmaceuticals for managing high ROI.


Course Title: KPE’s Certificate Course in Drug Development to Commercialization


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Course Title: KPE’s Certificate Program in Intellectual Property Management in Pharmaceuticals

Course Objective: The objective of this course is to impart knowledge and understanding of effective Innovation management process in Pharmaceuticals.

This online course utilizes interactive learning tools to guide each participant through the Intellectual Property Management in Pharmaceutical Industry. The course is designed to challenge students to apply what they have learned through the use of interactive exercises, reflection questions, expert live chat and a final assessment at the end of the course.



1. Overview of Intellectual Property Rights – Trademark, Copyright, Patent

2. Intellectual Property Management in Pharmaceutical Companies

3. Practical Training in handling Patent, Trademark Registration

4. Drug Regulations and Intellectual Property Management

4. Strategic Planning in Intellectual Property Management

5. Licensing – In Licensing vs. Out-Licening

6. Controversy – Compulsory Licensing


Course Title: KPE’s Certificate Course in Intellectual Property Management in Pharmaceuticals


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Course Title: KPE’s Certificate Program in Drug Registration in GCC Countries

Course Objective: The objective of this course is to impart knowledge and understanding of Drug Registration Procedure in GCC countries, Regulations, Registration procedure, country specific Common Technical Documents, GCC guidelines and dossier preparation.

This online course utilizes interactive learning tools to guide each participant through the steps of drug regulation and registration process for the GCC countries. The course is designed to challenge students and Professionals to apply what they have learned through the use of interactive exercises, reflection questions, expert live chat and a final assessment at the end of the course.

The course can be completed at any place, allowing the user to stop and start at their leisure.

Part 1: Introduction to Drug Regulatory Affairs – Basic Understanding

Part 2: Overview of GCC countries – Country Introduction

Par 3: Introduction to Drug Regulation and Registration Process of the each specific countries

Part 4: Difference between US Market, Europe Market and GCC Market

Part 5: Overview of GCC Markets – Pharmaceutical and medical devices, Scope of Export – GCC countries

Part 6: Common Technical Documents – Live Practical Dossier – Open source file will be provided for easy understanding and competency development perspective

Part 7: Drug Dossier Preparation – Practical Sessions

Part 8: Export Documentation process – Process of handling effective export documentations

Part 9: GMP management process – E-lectures, case studies to explain GMP requirements

Part 10: Key Learning Summary and Notes




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This online course utilizes interactive learning tools to guide each participant through the steps of quality assurance working and managing quality documentation procedures in pharmaceutical companies. The course is designed to challenge students to apply what they have learned through the use of interactive exercises, reflection questions, expert live chat and a final assessment at the end of the course.


Course Objective: The objective of this course is to impart knowledge and practical understanding about the Quality Assurance department and core quality assurance method, process and practices. Special emphasize on quality documentation process handling.

This online course utilizes interactive learning tools to guide each participant through the steps of quality assurance working and managing quality documentation procedures in pharmaceutical companies. The course is designed to challenge students to apply what they have learned through the use of interactive exercises, reflection questions, expert live chat and a final assessment at the end of the course.

Course Title: KPE’s Certificate Program in Medical Device Regulations.

Course Objective: The objective of this course is to impart knowledge and practical understanding about the Medical Devices types, regulatory overview and approval process of Medical Devices.

This online course utilizes interactive learning tools to guide each participant through the steps of medical devices regulations and approval process in details. The course is designed to challenge students to apply what they have learned through the use of interactive exercises, reflection questions, expert live chat and a final assessment at the end of the course.


Who should attend?

Regulatory Affairs professionals seeking to improve their skills in the regulatory environment Those moving into regulatory affairs from other areas within a medical devices company (Pharmacists, Clinical Trials, Marketing and others) Anyone wishing to update their knowledge on Medical devices industry Anyone who want to know / update about the Medical Devices Business Management / Strategic Plannings


1. Overview of medical devices – Introduction, Classifications and Designs.

2. Understanding of the different classes of medical devices in detail.

3. Practical knowledge of medical devices approval process (Pre market requirement)

4. Detailed understanding of the Quality Documentation

5. Handling of the Product Complaint & Product Recall.

6. Handling of Product Withdrawal from market.

7. Marketing, Advertising, Promotion of the medical devices

8. Strategic Business Model for the medical devices companies.


Course Title: KPE’s Certificate Course in Quality Assurance & Documentation



Course Title: KPE’s Certificate Course in Medical Devices Regulation


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This online BIOSIMILAR REGULATION AND REGISTRATION training course utilizes interactive learning tools to guide each participant through the steps of the project management process which takes place in the pharmaceutical, biotech keeping focus in BIOSIMILAR industry. The course is designed to challenge students to apply what they have learned through the use of interactive exercises, reflection questions, expert live chat and a final assessment at the end of the course.


Biosimilar Regulation and Registration course is structured as follows:

Introduction to Global Pharmaceutical Industry, Indian Pharmaceutical Industry, Overview of General Regulation Drug Discovery and Development Process Introduction to Biotech Industry – Global and Indian. Leading Biotech companies and their product and pipeline analysis Regulation in Biotech Industry Introduction to Biosimilar. Difference between biosimilar and generid drugs Key important issues in Biotech and biosimilar product manufacturing GMP requirements in biotech industry General approval process of biosimilar products Biosimilar Development project management – timeline creation with business outcome

Country specific regulation in Biosimilar Products -

Biosimilar regulation and registration in India Mexican guidelines for biocomparables Biosimilar regulation in US & US exclusivity of biosimilar Biosimilar policies in the UK, Use of biosimilars in Europe, EMEA regulation on biosimilar Registration of biosimilar in colombia Canadian guidelines for biosimilars WHO guidelines on biosimilars: case studies and discussion highlights Turkish guidelines for biosimilars Proposed biosimilars guidelines for Chile Biosimilar approval in Egypt Malaysian guidelines for biosimilars Health Canada views on generics and biosimilars


Course Title: KPE’s Certificate Course in Biosimilar Regulation & Registration


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Course Objective: The objective of this course is to impart knowledge and practical understanding about the Drug, biotech and medical devices Regulatory Affairs and approval process in US.

Course Description - This online course utilizes interactive learning tools to guide each participant through to understand of the USFDA regulatory structure and ensure that your submissions meet the standards required by the regulators. The course will focus on understanding the European legal & regulatory environment; the registration procedures that are available, and the structure of the registration dossier. The course will adopt a practical and interactive approach that will enable you to apply what you have learned to your daily work the steps of approval process in details. The course is designed to challenge students to apply what they have learned through the use of interactive exercises, reflection questions, expert live chat and a final assessment at the end of the course.The course can be completed at any pace, allowing the user to stop and start at their leisure.

Who should attend?

Regulatory Affairs professionals seeking to improve their skills in the regulatory environment Those moving into regulatory affairs from other areas within a pharmaceutical company (Pharmacists, Clinical Trials, Marketing and others) Anyone wishing to update their knowledge on European regulatory affairs Regulatory Affairs, Registration and Documentation assistants/officers/managers

Course flow:

USFDA Pharmaceuticals / Biotech Regulation, R&D Process & Introduction to drug discovery, Investigational New Drug Application (INDA), New Drug Application (NDA), Basic concept and understanding of the Generic Drug, DRA working in DRA department, Abbreviated New Drug Application (ANDA), Generic Drug User Fees Act (GDUFA), Prescription Drug User Fees Act (PDUFA), Handling of orange book, Priority Accelerated Review, Practical Training on INDA and ANDA filling, Promotion Advertisement Regulations (Practical), Dossier Reparation, Introduction to Common Technical Document (CTD), Advance Practical Training on Dossier Preparation focusing on drug registration in export countries, Assignment and real life dossier preparation – step by step guideline, Overall understanding of dossier compilation process, Modules on Stability Study, Module on Interchangeability, Stability Testing of API, Stability Testing of Finished Pharmaceutical Products, E-CTD – Basics, Regulatory Strategies in different phases of Clinical Trial, DMF & SMF, Drug Master File, Site Master File, Practical Training on preparing DMF and SMF, Generic Drug Marketing Strategies, Advance study on Para IV Filing, Evergreening – Patent Life Extension Strategies, Advance understanding on Biotech & Biosimilar Drugs and Guidelines, Introduction to Biosimilar, Biosimilar Approval process, Biological Licensing Application (BLA), Vaccine development and approval Process, USFDA Warning Letter – Handling of warning letter, Formulation, Quality and Regulatory Manual for handling CAPA, Introduction to CAPA, Global Pharma Industry, Drug Registration in European Country – Understanding differences with the USFDA, Centralized Procedure, Decentralized Procedure, Mutual Recognition Procedure, Dossier Preparation for European submission

US Medical Devices Regulation -US Medical Devies Market – Introduction & SWOT Analysis, Definition of Medical Devices, Different Classes of Medical Devices and their working principal, USFDA – Classification for Medical Devices based on risk, USFDA – CDRH Overview, Medical Devices Regulation in US Introduction to Medical Devices

USFDA regulation - 510(k) pre-market notification, Pre-market approval, Details understanding of Pre Market Approval Process with flow chart, 510k VS. PMA, Investigational Device Exemption, De Novo Petition – Medical Devices Regulation, Investigational Device Exemption (IDE), Device Clinical Research, Early/Expanded Access of Medical Devices, Trials of Medical Devices, Humanitarian Device Exemption (HDE), Labeling Requirement for Medical Devices, Marketing, Advertising and Promotion of Medical Devices, Unapproved use of Medical Devices

EU Regulation of medical devices and differences with USFDA regulationMedical Devices: EU Directives, Classification and Guidance, CE Marking., Quality Management System (QMS) for medical devices company, ISO Certification for Medical Devices company, CE Marking for Medical Devices company, Medical Device regulatory professionals responsibility.


Course Title: KPE’s Certificate Course in USFDA regulation of Pharmaceuticals, Biotech and medical devices


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Course Title: KPE’s Certificate Course in Clinical Research

Course Objective: The objective of this course is to impart knowledge and understanding with an opportunity to acquire and develop the expertise necessary for effective clinical research. The program is designed to meet the high demand for trained personnel for human clinical trials. The program enable you to master practical aspects of clinical trial conduct and management including clinical trial phases and design, planning, implementation, data analysis, regulatory and procedural guidelines and ethical considerations.

This online course utilizes interactive learning tools to guide each participant through the steps by step understanding of clinical trial and clinical research. The course is designed to challenge students to apply what they have learned through the use of interactive exercises, reflection questions, expert live chat and a final assessment at the end of the course.



1. Overview of the Drug Discovery and Development Process.

2. Introduction to Drug Regulation and Registration Process.

3. Pre-clinical Trials – Methods and Analysis Technique. Training on GLP

4. Clinical Trials – Methods and Analysis Technique. Training on GCP.

5. GCP Audit handling procedure.

7. Strategies of Clinical Trials.

8. Clinical Publications handling.


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Course Objective: The objective of this course is to impart knowledge and understanding of the Pharmaceutical Project management keeping in view of pharmaceutical, biotech and biosimilar industry in mind.

This online Project Management training course utilizes interactive learning tools to guide each participant through the steps of the project management process which takes place in the pharmaceutical, biotech keeping in view both in innovative and generic industry. The course is designed to challenge students to apply what they have learned through the use of interactive exercises, reflection questions, expert live chat and a final assessment at the end of the course.


Who should attend?

Regulatory Affairs professionals seeking to improve their skills in the pharmaceutical business and regulatory affairs Those moving into regulatory affairs / project management Anyone who will be working at portfolio management projects of pharmaceutical companies

Pharmaceutical Project Management course is structured as follows:

Strategic look into pharma project management. Turns to the key links of pharma projects with pharma business strategy. Introduction to Project Management, terminologies and advance content of the project management. Introduction to Project Management, Beginning a

Project, Project Planning, Project Budgeting, Project Scheduling, Project Execution, Monitoring and Controlling the Project, Summary of Project Management Knowledge, Tools To Help Make a Project Manager Succeed.

Drug Discovery Development project management – timeline creation with business outcome Project Evaluation process Financial knowledge for pharmaceutical industry Project Execution Cutomized formats, charts, logs for detailed project management systems and controls. Practical Training on documentation Handling of IT system and Project software

Overview of at a number of generic types of projects and explores. some tailored checklists for applying project management to them. These include:

R&D projects – Drug Discovery Management Project R&D projects – Biosimilar industry Business and brand acquisition projects; Corporate Level project management Strategic alliance and joint venture projects; operational improvement projects – Formulation Project – Parenteral operational improvement projects – Formulation Project – Solid Dosage Form (Tablet, Capsules, pills) operational improvement projects – Formulation Project – Semi – Solid Dosage Form (Tablet, Capsules, pills) operational improvement projects – Formulation Project – Liquid Dosage Form Costing of pharmaceuticals and cost management projects organisational change projects.


Course Title: KPE’s Certificate Course in Pharmaceutical Project Management


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“I did my M.Pharma, then working as Lecturer in Gautam College of Pharmacy, Bangalore. Unique Practical oriented course helped me to get into the industry. KPE course is unique and I gained extensive working knowledge what industry looks for.”

I wanted to thank u for your time and effort in teaching a course with such an extensive array of topics. This course give me the chance to learn and implement new skills. I was highly impressed with this course and your great help and knowledge & thanks to whole team of NCK Pharma for their outstanding service.

Gobinda Behera- Product Managercsmo nextierr Private Ltd.

Kanchan Ugarshandi MCDIL Laboratory, Quality Assurance Analyst

Anish Mojar - Product ManagerAmpus Life Sciences Limited

“The industry oriented practical knowledge, real life case studies as well as current industry news KPE in a new way of E-learning.

Placements: The industry wide network & high reputation of KPE courses have made easy to place the students across reputed pharma companies. It has been a great help to me in getting the right opportunity & the job of my dream in pharmaceutical industry."

In a relationship each person should support the other; they should lift each other up. My name is Suman Munugoti, completed Masters in Pharmacy from Kakatiya University – Warangal. I am interested in Pharmaceutical Regulatory Affairs course and got to know regarding NCK from internet search. I approached them through mail and got career counselling. Once I joined the course I am impressed with the quality of education they providing which the courses are approved by International Association of Distance Learning (IADL), 24/7 Live chat, personalized web page audio lectures, Course Modules, Secure online final examination of my convenience and followed by my placement !!!I would like to thank all NCK team members for providing such beautiful featured courses and especially to Mr. Saikat Roy who is my mentor during my course duration for all his support which makes me successful in my career.

Suman MunugotiProduct Manager - Opthalmic (Gravis Inc. US)

I would like to say big thanks to NCK. Really this course is very properly designed. It will really help me in future. i will also tell my friends about this course. Your assist throughout course very caring. Thanks a lot. I am really proud member of NCK PHARMA. Take Care.

Vivek Tarate - Twilight Litaka Pharma Ltd.(M.Pharm, ADPDRA)

What students says:

Thank you for timely result and awesome experience with this course. Really learned a lot from it.

I Really appreciated the personalized attention i received during my 1 year Advance Diploma in Pharmaceutical Product Management.. They all Went above and beyond in helping me to achieved a well established career in PMT.I would like to compliment the PMT Team of NCK Pharma Pvt.Ltd, for its quality education & dedication for their student.Thanks to the whole Team of NCK for their outstanding service.

Manish Prasad Product Manager - BPRL Private LimitedB.Pharma from MS Ramaiah College of Pharmcy

Ankit GeeteAnalyst, Regulatory Operations at Accenture Accelerated R&D ServicesMS from NIPER - Mohalli

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I have always received good service from the NCK group. Timing and quality have always met my expectations and everything is communicated in a professional and timely manner. As an online course it allowed me to study where and when I wanted, but it was more than just that. The support from NCK was first rate, while the course was well paced and pitched at a level which allowed me to learn quickly and in depth . I always used to discuss with my friends about the platform they are creating for pharma students . Assistance throughout the course is very caring. Vidhu Pandey (M.Pharma –

M.S. Ramaiah College of pharmacy)

This was a great online class experience for me (the first one that I've completed!). I think the personal touch through the phone sessions, combined with the e-mail responses from NCK when I had questions helped a lot!

Haritha B ( B.Pharm)-M.S. Ramaiah College of PharmacyMedical Engagement- Indegens Life Systems

www.nckpharma.comR

Top Performer - Advance Program 2014

Top Performer - Certificate Course 2014


Neha Prashar – MS-NIPER, Mylan Laboratories R. Subhash Vallab – (PMT – Tidal Laboratories Pvt. Ltd.) Ankit Geete, Regulatory Affairs – Accenture (INDIA),

MS- NIPER (Mohalli)

Swecha Reddy (Germany) Ankit Geete, Regulatory Affairs – Accenture (INDIA), MS- NIPER (Mohalli)

Amita Kajrolkar15 Years experience in pharma

sales and marketing.Working at Lotus Research (INDIA)

Frank Alapini, US, Medical Practitioner (USA)

Firdos Shera, MS-NIPER, Working at P-CON Consulting (INDIA)

Haritha B (B.Pharma – M.S. Ramaiah College of pharmacy)

Medical Engagement – Indegens Life Systems


Suresh Devaka, R&D – Dr. Reddy’s Laboratory Bevera Pardha Saradhi, R&D –

Dr. Reddy’s LaboratoryGiorgio Ferrari, Italy – Medical Doctor with PhD

in Forensic Medicines. (ITALY)

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91.50%91.36% 87.70%

91.44% 90.97% 90.27%

88.85%

94%

87.83%

94%

82.90%

82.21%

www.nckpharma.comR

Amita Kajrolkar15 Years experience in pharma

sales and marketing.Working at Lotus Research (INDIA)

Haritha B (B.Pharma – M.S. Ramaiah College of pharmacy)

Medical Engagement – Indegens Life Systems

Gaurav Negi (Regulatory Affairs in Axa Parenteral)

Giorgio Ferrari, Italy – Medical Doctor with PhD in Forensic Medicines. (ITALY)

Achieved distinction distinction in all three courses he undergone.Drug Regulatory Affairs, Drug Discovery Development to commercialization and Pharma Product Management.

Achieved distinction distinction in all two courses he undergone. Pharma Production Management & Pharmacovigilance.

Achieved distinction distinction in all two courses he undergone. Drug Regulatory Affairs & Medical Devices Regulation.

Achieved distinction distinction in all two courses he undergone. Drug Regulatory Affairs & Pharmacovigilance.

Achieved distinction distinction in all two courses he undergone. Drug Regulatory Affairs & Drug Registration in ASEAN countries.

Vidhu Pandey (M.Pharma – M.S. Ramaiah College of pharmacy)

Outstanding Performer in Pharmaceutical Strategic Management

Some other Noteworthy Performers

Danis M. Loyed (MBA, strategic consultant V-CON Pharma)Eric Benard (Regulatory Manager – Emmex) ThilandAmruta Shinde (M.Pharma)Asfaq Ahmed (B.Pharma)Abhijit Naha (Persuing MBA)Shankar Kurbet (Sr. Manager Reg affairs & Product Maintanance at Novartis India Limited)Akash Malhotra (B.Pharma)Aman Rathi (MSC Microbiology)Avik Meheta (Management Trainee – NCK Pharma)Arinda Paul (Indospec)Jayant Jain (PhD) Avinash Nayak (MBA, Persuing PhD, Pharma Consultant)Dr. Richard M. (Medical Practioner) USJignesh Patel (B.Pharma)Kanchan Ugur sandi (B.Pharma – M.S Ramaiah College of Pharmacy)Shah Mayur Rohit Kumar (MBA - KBIPER)Ashutosh Konwar (Biocon)Bhpendra Kumar Yadav (M.Pharma, Rungta College of Pharmacy) Yadav Power (M.Sc, persuing PhD)Avik Meheta (Management Trainee – NCK Pharma)Amita Kajrolkar (One Lotus Research)Manish Prasad (Product Manager, Sagar Pharmaceuticals (BPRL group)Rohini Patil (M.Pharma)Mahesh Yata (Astra Zeneca)Firdos Shera (Pcon)Jovi Nicol. (MS, PhD, US)Polikand M (MBA persuing)Arun Kumar Thriveedhi (Dr. Reddy’s)Dr. Girogio Ferrari (Italy, National Health System)Amit Singh (B.pharma)Rajeev Dadar (BSC, Persuing MBA)Samshad Alam – Magnus Pharma, Nepal)Gourav Negi (Axa Parenteral)Anil Dabade (B.Pharma, Nives Consulttant)Nilesh Jani (B.Pharma persuing)Abhijit Naha (Persuing MBA)Danie Pasrlo (Armenia)Yasin K. (saudi Arabia)Rudolph Cisneni (Dinoaz, Brazil)Dr. VL Namrata (Pursuing PhD from Sweden)Araindam Paul (M.Sc, Project Trainee)KS Ganga (M.Pharma)Gobinda Behera (Product Manager, Wintac Limited)Dudescu E.S. Raluca Corina – (Romania)Arpita Kothari (Indus)Alok Das(persuing MBA)Ajit Kapoor (Alkem)Soniya PS (B.Pharma persuing) Monika Rai (Product Manager, Ronyd Healthcare)Dr. Frank Alapini (USA, MD Medicine)Vivek Tarate (Twilight Litaka)Kiran Kumar Suggu (Medo Pharma)Dr. Priya Kothari (Persuing PhD)Navreet Kaur (B.Pharma, Ram Gopal College, Delhi )Anish Mojar (Product Mangaer, Ampus Lifesciences)Jawad Ali (GPC)Ashish Kr. Singh (Ram Gopal College, Delhi)Hemlatha Kovealamudi (Manipal College of Pharmaceutical Sciences, Manipal)Gaurav Negi – (Axa Parenteral)Safal Jain (Lipoxen, UK)Jalpesh Kathiriya (B.Pharma)Urvashi Rathi (B.Pharma, Fresher)Rases Patel (New South Wales, Australia)Manjesh Jadon (B.Pharma)Mohammed Nazran (Ex-Pfizer, B.Pharma, Nitte College of Pharmacy, Mangalore)

Rajesh Madhavan (Regional Business Manager -Dr. Reddy's Laboratory)


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Important FAQs related to the course

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What is the eligibility criteria for the course?Advance Diploma / Certificate Course - Graduation in any discipline. 3rd and Final year graduation students can undergo the course.

Executive Program - Graduation in any discipline and minimum work experience 5 years in managerial role is mandatory for admission.

Do I receive printed books? Yes. You will be receving the printed books based on which particular course you opted for. For admission within India printed booklet will be sent to correspondance address. For admission outside India, pdf e-book will be sent to registered email id.

How to register for final examination?you can register by mentioning NAME, ENROLLMENT ID, EMAIL ID, COURSE CODE, EXAMINATION DATE AND TIME by sending to [email protected]

Can I change registered final examination date and time?Yes you can upto 72 hours before. But within 72 hours of exam time you will not be able to change the date.

What if I failed to pass / could not attend the examination?You need to reappear for RE-EXAMINATION. You will be able to appear the RE-EXAMINATION only after 30 days from the date of previous examination.You need to take the RE-EXAMINATION date and appear as per the approved date.

Is there any exam fees for final examination?No. There is no separate fees you need to pay for final examination or RE-EXAMINATION.

What is the pattern of final examination?Generally final examination will have 150 marks.Time duration - Max. 3 hours (varies)Types of questions: Objective type, short explanatory type.

What is total certification marks and grades?Total certification marks is 200

Internal Assessment - 50Final Examination - 150

Grades:More than 75% - DistinctionMore than 60% - 1st ClassMore than 50% - Pass Class---------------------------------

For certification you need to secure 50% of overall and individually in Internal Assessment and Final Examination.In case of RE-EXAMINATION grades will not be available. Only PASS grade will be provided.

When I can register for final examination?For 1 Month Certificate course - After 28 days you can take the final examination. Up to 40 days from registration you are eligible to take the examination.For 1 Year Advance Diploma Program - After 11th month i.e 12th month you can take your final examination up to 14th month.

Before 7 days of scheduled date of examination you can register for the final examination date and time.

When I will be getting my certification after successfully passing the final examination?You will be receiving the final examination result immediately with 72 hours of final examination. Certificate will be issued in next 7 working days time.

Do I get the certificate after completion of the course?Yes. You will be awarded with certificate after successful completion of the course.

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Important FAQs related to the course

I have further doubts. How should I clarify?Option 1: You can mail us at [email protected] 2: You can submit details through the EMAIL US or Live Chat button aappearing in left side on your dashboard.

How the course modules are scheduled?Course Modules contain 2 types - Printed Modules (Books) and Online Access. Once Admission happens immediately you will be receiving the complete set of printed modules (books) in your correspondence address. Immediately, you can access the online page by visiting your dashboard. Generally you can start access the course immediately within 6-12 hours after payment (incase of payment through online payment gateway). Incase of payment through Demand Draft, access will be provided after realization payment.

Do 3rd and final year students can apply for the Advace Diploma Courses?"]Yes , 3rd and final year students can apply for the course. They can submit the final year graduation record to us once completed. In case your final year graduation result is waiting and in meantime you completed the course, you will be receiving the provisional certificate and later on producing final year graduation marks card, you will be receiving final certificate.

Do certificate valid across the countries?"]As course is approved and accredited by the International Association of Distance Learning, certificate is valid across the countries.

Can I complete the Advance Diploma course within 6 months?You can convert the course (after enrolling) into the Fast Track Conversion, where you can write/ take examination immediately on completion of 6 month. Infact you can schedule your examination based on your convenience. Please note for advance diploma program you can not write the final examination within 6 month from date of admission.

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Admission Process

Online Admission Offline Admission

1

2

Step

Step

3Step

4Step

5Step

Create a Free account by clicking "Sign up" button on top right corner of the www.nckpharma.com. Provide relevantinformation and work experience details (under additionalcomment tab).

Login with your user id and password into the site and go to desired course you want to purchase.

Click BOOK NOW button and book the relevant course

Make payment online by clicking PAY FROM INDIA link.

Upon completion of the payment go to your page and update payment details (attachment). Our admin upon receiving payment will activate your course. Upon activation you can visit your dasboard and start accessing the course by visiting Confirmed Course / Attended Course link.

1

2

Step

Step

3Step

4Step

1

2

Step

Step

3Step

4Step

5Step

Take Print out of the admission form.

Fill up the admission form with the relevant details.

Take Demand Draft in favour of NCK PHARMA SOLUTION PRIVATE LIMITED payable at Delhi.

Courrier the Application Form and DD to


Upon receiving your admission details and payment, your account will be created and user id and password will be provided to you. You can start access the course.

Admission From India

Admission From Outside India

Create Free Account by clicking Sign Up button at the top of the page.

Login with your user id and password into the site and go to desired course you want to purchase.

Click BUY NOW button and pay the course fees by Credit card, debit card or paypal.

Upon completion of the payment go to your page and update payment details (attachment). Our admin upon receiving payment will activate your course.

Online applicant also need to download the form and fill up all the details and scan copy / photo of the same need to send as email attachment to from [email protected] email id.

Online applicant also need to download the form and fill up all the details and scan copy / photo of the same need to send as email attachment to [email protected] from registered email id.

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Personal Details

Affix yourrecent colourpassport size photograph

I. Course applied for

II. Registration No.(To be given by the office)

1. Name Mr./Ms.

2. Father’s Name Mr.

Date of Birth

D D M M

Age Gender M / F

Blood Group Nationality Indian / Others

Correspondance address.............................................................................................................

....................................................................................................................................................

.................................................................................................Pin

Tel No.........................................................................Mobile........................................................

Email............................................................................

Course Application Form

Y Y

SIGNATURE OF THE APPLICANT

To,

The Director,

NCK Pharma Soluon Private Limited

Knowledge Process Enhancer Program

Sir,

I wish to apply for the following course and I will abide by rules and regulaon of the Knowledge Process TMEnhancer Program if my registraon is approved by the Director of the KPE Board of Studies. I cerfy that

informaon given by me in this registraon form is correct and complete to the best of my knowledge and

belief.

DATE: .................................

PLACE:.................................

Academic Qualification (Mention X, XII, Graduation , PG , other details - with percentage)

Work Experiences (Organization, Designation and Duration)

Fees Payment Details

Choose the appropriate payment option

DD

NEFT

Bank

Bank

DD No.

Transaction Id

Transaction Id

Amount Paid: ----------------------

Online Payment Gateway

R

Duly filled application form should be send to mention address

KPE-C-

NCK Pharma Solution Private Limited World Trade Center, 22nd floor, Unit No. N 2201, Brigade Gateway Campus, No.26/1, Dr.Rajkumar Road, Malleswaram West, Bangalore – 560 055, India. Mobile: +91-98455 71046

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Sample Certificate

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SAMPLE

SAMPLE

www.nckpharma.com


NCK Pharma Solution Private LimitedWorld Trade Center, 22nd floor,Unit No. N 2201, Brigade Gateway Campus,No.26/1, Dr.Rajkumar Road, Malleswaram West,Bangalore – 560 055,India.Mobile: +91-9845571046

Email: [email protected]

Web: www.nckpharma.com

Release Note: 2015/Feb/2.3


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