Address for correspondence:Dr. S. Sunitha

NIPER, Hyderabad

Balanagar, Hyderabad – 500037

E-mail: Ph: +91(0) 40 – 23073741/40d2c2niperhyd@gmail.com;

Eligibility Criteria

NIPER-Hyderabad

National Institute of Pharmaceutical

Education and Research (NIPER) is

an autonomous body established

under the aegis of Ministry of

Chemicals & Fertilizers, Department

of Pharmaceuticals, at Hyderabad as

a centre of excellence for higher

education, research and development

in pharmaceutical sciences. The

institute has been declared as an

“Institute of National Importance” by

Govt. of India through an Act of Parliament (NIPER Act 1998 & NIPER Amendment Act 2007).

Key objectives :

Enhancement of creativity, motivation, drive and inculcate professionalism

To bring synergy between academic, R&D, technology and industry through training

and exposure for such environment.

To prepare professionals to suit to the need of pharmaceutical industry.

To create a world class institute of teaching and research in the field of

pharmaceutical sciences.

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Participation Certificate

Registration Fee: (Covers workshop material, participation in meetings, refreshment and lunch for the days of workshop)

Registration Details

Early Bird Registration fee(before 24-Aug-2012)

Actual/Spot Registration fee(after 24-Aug-2012)

Student

Per Module

1,500

Full Course*

Faculty

Per Module Full Course* Per Module

1,650

3,600

3,950

3,000

4,500

7,000

8,500

6,000

6,500

*Discounted fee for full course (3 workshops)

Who should attend ?

Students/Scholars enthusiastic to get into the field of drug discovery

Professionals wanting to change career within the industry/academia

Personnel in industry and academia requiring comprehensive training in Drug Discovery

* Each workshop module has both theory and hands on experience/demonstration

Workshop*

Module 1(Drug Discovery, Pre-clinical and

Clinical)

Module 2(Medical Writing,

Regulatory Affairs & Pharmacovigilance )

Module 3(Product Development,

Analytical, IPR & Marketing)

Flowchart of workshop

Dr. J. S. Yadav (IICT, Hyderabad)

Dr. Ahmed Kamal (IICT & NIPER, Hyderabad)

Prof. N. Satyanarayana (NIPER, Hyderabad)

Dr. R. Srinivas (IICT & NIPER, Hyderabad)

Dr. S. Ramakrishna (IICT & NIPER, Hyderabad)

Dr. A.Krishnam Raju

Prof. V. Peesapati

Dr. Nalini Shastri

Organizing Committee:

Workshop design:

The workshop has invited lectures by eminent scientists/professors from industry/Academia in the field of

drug discovery, development and commercialization. Lecture sessions are accompanied by hands-on drug

discovery experience and demonstration of special techniques/experiments in relevant topics. It is designed

as three modules and each module of three days duration, over a period of three months. The main goal of the

workshop is to build and enhance knowledge and skills of students and professionals working or intending to

work in drug discovery, development and commercialization awareness.

Key Objectives:

To train professionals catering to the needs of pharmaceutical industry

To provide an opportunity to interact with experts from the field of drug discovery & development

Industry

Full Course*

14,000

16,000

Awards and honours:

The faculty is honored with OPPI Scientist; OPPI Young Scientist and IDMA Young

Pharmaceutical Analyst Awards for their research contribution.

Research Publications:

45 Peer reviewed International / National Publications (Past 4 years).

Created new Research laboratories.

Created good auditorium and spacious lecture halls with modern teaching tools.

Well equipped molecular modeling lab and CPCSEA registered animal quarantine

facility.

Established its own website and institutional email facility.

Faculty members are honored with editorial board of reputed international journal and

serving as reviewers.

Poster Presentations:

About 35 Posters were presented at different Conference / Symposia by the faculty

and students

Received best oral and poster presentation

Organised good number of Conference and Workshops like:

D4PS-2010

Bioinformatics@BioAsia-2012

American Association of Pharmaceutical Sciences (AAPS) - nd2 PharmSci@India-2011

Computer aided drug design and discovery:CAD3-2010/11

MEDCHEM Congress-2011th4 CRSI-RSC Symposium in Chemistry-2010

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Achievements & Research Accomplishments

Drug Development:

Conceptualisation to

Commercialisation

(D @ C )2 2

Workshop on

Organized by:

Supported byDepartment of Pharmaceuticals

Ministry of Chemicals and Fertilizers, Govt. of India

atNational Institute of Pharmaceutical Education and Research

(NIPER-HYDERABAD), Balanagar, Hyderabad – 500 037www.niperhyd.ac.in

Initiative supported for knowledge sharing by Novartis, Hyderabad

A Participation Certificate will be given to participants attending one or more modules.A Course Certificate will be given to the participant attending all three modules.

Any Graduate from Science/Pharmacy or allied fields

For Industry participants one day or two days in a Module according to the convenience of the participants,

where for 1 day it will be charged Rs. 3,000/- and for 2 days it will be Rs. 6,000/-

Mode of payment: Registration Fee may be paid through Demand Draft drawn in favour of

“NIPER - HYDERABAD”, payable at Hyderabad.

Dr. N. Shankaraiah (NIPER, Hyderabad)

Dr. Narendra Kumar Talluri (NIPER, Hyderabad)

Dr. S. Sunitha (NIPER, Hyderabad)

Dr. T. Venu (NIPER, Hyderabad)

Dr. A.Krishnam Raju (NIPER, Hyderabad)

Prof. V. Peesapati (NIPER, Hyderabad)

Dr. Nalini Shastri (NIPER, Hyderabad)

*Based on the availability, speakers may change.

Module 1

Drug Discovery, Pre-clinical and Clinical

thDay 1: NIPER (30 Aug. 2012)

stDay 2: NIPER (31 Aug. 2012)

stDay 3: NIPER (1 Sept. 2012)

Overview of Drug Discovery and Development (with phases)

Pre-clinical studies

Global Clinical Development

Ethical Conduct of Clinical Trials

Quality of Clinical Trials

How to design and conduct a clinical trial

Role of Statistics in Pre-Clinical Research

Clinical Database Design and Data Management

Planning and logistics of a clinical trial

Project Management of a trial

From Data Capture to Statistical Analysis

Auditing a clinical trial

Overview of Clinical Data Challenges

Data Management for Vaccine Studies

Course Content

Module 3

Product Development, Analytical, IPR & Marketing

thDay 1: NIPER (18 Oct. 2012)

thDay 2: NIPER (19 Oct. 2012)

thDay 3: NIPER (20 Oct. 2012)

Development and Analysis of Active Pharmaceutical ingredients

Development and Analysis of Formulations – Conventional products

Novel Drug delivery technologies

Bioanalytical Methods

IPR for Pharmaceutical Research.

Intellectual property, patenting and commercialization.

Basics of Pharma Marketing

Promotion of Pharma products

Marketing plan

High through Put Screening

Course Content

List of Speakers*

Module 2

Medical Writing, Regulatory Affairs

& Pharmacovigilance

thDay 1: NIPER (27 Sept. 2012)

thDay 2: NIPER (28 Sept. 2012)thDay 3: NIPER (29 Sept. 2012)

Medical Writing as a profession-Key skills

How to writer a publication-View from an editor

Regulatory Affairs

Pharmacovigilance

Writing patient narratives

Case reporting and processing

Work shop on Pharmacovigilance

Course Content

Dr. Ahmed Kamal (IICT, Hyderabad)

Dr. Ramesh Bambal (Daiichi Sankyo India Pharma Pvt. Ltd, Gurgaon)

Dr. Dinesh Kumar (NIN, Hyderabad)

Dr. Julius Vaz (Novartis, Hyderabad)

Dr. Geeta Rajashekhar (Qualtox Consultancy, Bangalore)

Dr. Usharani Pingali (NIMS, Hyderabad)

Prof B Unnikrishnan (Manipal University)

Dr. Ashwini Mathur (Novartis, Hyderabad)

Dr. Mahesh Iyer (Novartis, Hyderabad)

Dr. Dipen Khanna (Novartis, Hyderabad)

Dinesh Pillaipakkamnatt (Novartis, Hyderabad)

Prof N. Udupa (Manipal University)

Dr. Ranjini Nellore (Pharmantra Consultancy)

Dr. Bhaskar (Granules India, Hyderabad)

Dr. Jagannath Kota (Novartis, Hyderabad)

Dr. Parag Borde (Novartis, Hyderabad)

Dr. Sridharacharyulu (NALSAR University, Hyderabad)

Dr. Parikshit Bhansal (NIPER-Mohali)

Dr. S. Chandra Shekar (IICT,Hyderabad)

Prof. Y. Madhusudan Rao (UCPSC, Kakatiya University)

Prof. S.S. Apte (Natco, Hyderabad)

Dr. R. Srinivas (IICT,Hyderabad)

Dr. R. Nageswar Rao (IICT,Hyderabad)

REGISTRATION FORM(Please tick in the box against the module you would like to attend.

You can tick in more than one box as applicable.)

Workshop on

Drug Development:

Conceptualisation to

Commercialisation

(D @ C )2 2

Module 1

Drug Discovery, Pre-clinical and Clinicalth st30 Aug. - 1 Sep. 2012 at NIPER, Hyderabad

Module 2

Medical Writing, Regulatory Affairs & Pharmacovigilance th27-29 Sep. 2012 at NIPER, Hyderabad

Module 3

Product Development, Analytical, IPR & Marketingth18-20 Oct. 2012 at NIPER, Hyderabad

Registration Fee: (Covers workshop material, participation in meetings, refreshment and lunch for the days of workshop)

Registration Details

Early Bird Registration fee(before 24-Aug-2012)

Actual/Spot Registration fee(after 24-Aug-2012)

Student

Per Module

1,500

Full Course*

Faculty

Per Module Full Course* Per Module

1,650

3,600

3,950

3,000

4,500

7,000

8,500

6,000

6,500

*Discounted fee for full course (3 workshops)

Industry

Full Course*

14,000

16,000

Address for correspondence

Dr. S. SunithaNIPER, Hyderabad

Balanagar, Hyderabad – 500037E-mail: d2c2niperhyd@gmail

Ph: +91(0) 40 – 23073741/40

REGISTRATION FORM

Name (Surname first): ______________________________________

Mr. Ms. Mrs. Dr. Prof.

Organization: _____________________________________________

Mailing Address: ___________________________________________

__________________________________________________________

__________________________________________________________

Phone (with STD code) /Mobile: ________________________________

Email ID: __________________________________________________

Registration type: Student Faculty Industry

Registration fee: ____________________________________________

Issuing Bank: ______________________________________________

Bank Draft No. ___________________________Date: _____________

DD drawn in favour of “NIPER - HYDERABAD”, payable at Hyderabad.

Accommodation will not be provided by the organizers.Participants are requested to arrange for their own accommodation.

Mode of payment: Registration Fee may be paid through Demand Draft drawn in favour of

“NIPER - HYDERABAD”, payable at Hyderabad.Please attach your brief biodata (max 2 pages)

stating your qualification and experience.