SESSIONS Global Pharmaceutical Regulatory Affairs Summit · Global Pharmaceutical Regulatory Affairs Summit 18 ... Global Pharmaceutical Regulatory Affairs Summit 18 ... Menarini

Pre-Conference Evening Seminar:Implementing a Robust Strategy for ManagingeSubmissions in a Diverse Global Environment

18:00 - 20:30Global eSubmissions

Topics to be discussed include:

• Overview of the status of eSubmissions globallyincluding which countries are accepting eCTD,other types of eSubmissions or paper

• Reviewing whether the current degree of globalharmonisation in submission requirements willimprove

• Best practice for managing global submissions in asynchronised and harmonised way

• Understanding specific documentationrequirements in different regions and how thesecan be created successfully and efficiently

• Assessing varying expectations for submissioncontent and format in different regions

• Determining whether separate submissions mustbe made for the same registration in severalregions, or whether one submission will suffice

Participants

Suzie Henderson, Takeda Development Centre Europe,UK

Pre-Conference Evening Seminar: BestPractice for Conducting Multi-Regional ClinicalTrials in the Emerging Markets

18:00 - 20:30Emerging Markets Pre-Conference Evening Seminar

Multi-regional clinical trials (MRCT) are now beingconducted extensively in emerging markets with drugdevelopment being dramatically globalised in recentyears. Despite the advantages that come with MRCTincluding faster development processes and shorterapproval times, they do come with challenges.

This interactive evening seminar will provide attendeeswith a comprehensive insight into optimal MRCTdesign and conduct.

Topics to be discussed include:

• Case examples of successful MRCT design andconduct

• Understanding the key pros and cons of carryingout MRCTs

• Examining how to design MRCTs that successfullyaddress local population needs

• Showing how MRCTs can reduce approval time anddocumentation requirements for clinical trialapplications

• Overcoming coming key challenges experiencedwhen carrying out MRCT

Participants

Roger Joby, 1to1to1, UK

SESSIONSPRE-CONFERENCE EVENING SEMINARS - 17/10/2016

Global Pharmaceutical Regulatory Affairs Summit18 - 20 October 2016Maritim proArte Hotel

Berlin

lifesciences.knect365.com/global-pharma-regulatory-affairs

TIME EMERGING MARKETS PRE-CONFERENCE EVENINGSEMINAR

GLOBAL ESUBMISSIONS

18:00 18:00 - Pre-Conference Evening Seminar: Best Practice forConducting Multi-Regional Clinical Trials in the EmergingMarkets

18:00 - Pre-Conference Evening Seminar: Implementing aRobust Strategy for Managing eSubmissions in a Diverse GlobalEnvironment

SCHEDULEPRE-CONFERENCE EVENING SEMINARS - 17/10/2016


Berlin


Registration

08:00 - 09:00Main agenda

Opening remarks from the Chairperson


Overview of Russian National and EEUregistration process

09:10 - 09:45Emerging Markets Stream 1: Russia, CIS, Turkey,Middle East & Africa

• Exploring timelines with the Russian Federal LawNo. 429-FZ: Which amendments came into force 1July 2015, 1 January 2016 and 1 January 2017?

• Industry experience with interpretation andimplementation of the Russian amendments todate

• Comparing the Russian registration process withthe EEU process

Participants

Alexander Borisov, Teva LLC, Russia

Exploring the latest regulatory environment inBrazil and best strategies for productregistration

09:10 - 09:45Emerging Markets Stream 2: Latin America & Asia-Pacific

• Current regulatory environment and any recent orupcoming changes

• Working successfully with ANVISA• Comparing regulatory requirements in Brazil to

Europe• Overcoming the challenge of translating

regulations from local language and increasedtimelines

• Evaluating labelling requirements and expectationsin Brazil

Participants

Stefano Accorsi, CHIESI FARMACEUTICI S.p.A., Italy

Flash update: The EU eSubmissions Roadmap -what is upcoming, timelines and impact onindustry?


• Summary of the EU eSubmissions Roadmap• Outlining key timelines and milestones involved• Reviewing the impact on industry and expectations

that come with the Roadmap• Understanding and complying with EMA

requirements for eCTD baseline submissions

Participants

Melanie Ruppel, Boehringer Ingelheim Pharma GmbH& Co. KG, Germany

Interactive discussion session: Improvingcommunication between pharmacovigilance,labelling, regulatory affairs and riskmanagement to ensure compliant, relevant andtimely labelling updates

09:10 - 10:10Pharmaceutical Labelling

• Examining the extent to which labelling is driven bypharmacovigilance

• Assessing the risks to regulatory compliance ifseparate functions don’t communicate clearly

• Examining strategies to avoid working in silos• Optimising CMC and early gathering of documents

and data to streamline the process• Understanding the objectives of each stakeholder

and examining how these can become aligned

Participants

Patricia Lefebvre, Sanofi

Matthias Boedding, Merck Serono

Frederic Bouder,, Maastricht University

Simon Ashworth , Takeda Development Centre EuropeLtd.

EXTENDED ROUND TABLES SESSION: Updateand experiences with EU eCTD Module 1Specification v3.0 becoming mandatory from1st October 2016


The speaker will outline the latest status and changesimplicated by the EU eCTD Module 1 Specification v3.0which will become mandatory on 1st October 2016.Following the presentation, attendees will be split intosmaller groups to share experiences and challengesfaced so far with submissions using the updatedversion.

• Outlining the objectives and timelines involved withthe new eCTD Module 1 Specification

• Assessing industry experiences so far and any newprocesses or systems that need to be created

• Examining the review process of regulatoryauthorities and their expectations

• Understanding how vendors have adapted theirsystems to align with the new eCTD Module 1Specification

• Overcoming key challenges experienced andensuring business processes are not slowed down

Participants

Alastair Nixon, GlaxoSmithKline Research &Development Limited, UK

Exploring the new and upcoming Russian GMPinspection requirements for foreign drugs


• Clarifying GMP requirements in Russia andtimelines for coming into effect

• Reviewing the current status of the Russian GMPinspectorate

• Outlining how the GMP requirements will impactand challenge for foreign manufacturers

• Discussing whether GMP inspections areorganised yet and what documentation is missing

• Preparing inspection sites and communicatingwith the authority to agree inspection dates

Participants

Anna Zamakhaeva, Galderma, Russia

Brazil extended session


Attendees will be split into small groups for aninteractive discussion allowing them to shareexperiences with product registration and solutions tocommon problems in Brazil with other attendees.

Participants


SESSIONSREG AFFAIRS IN EMERGING MARKETS, ESUBMISSIONS & PHARMALABELLING DAY 1 - 18/10/2016

Global Pharmaceutical RegulatoryAffairs Summit

18 - 20 October 2016Maritim proArte Hotel

Berlin


Risk minimisation: Examining strategies toreduce medication errors through effectivelabelling


• Understanding regulatory expectations regardingrisk management

• Understanding the extent to which• insufficient labelling can be a source of adverse

events• Strategies for communicating the correct use of

the product to reduce the likelihood of medicationerrors happening

• Bridging the gap between pharmacovigilance andregulatory – labelling as a key risk minimisationmethodology

• Assessing the current challenge of communicatingrisk to patients through labelling

• Black box warning/black triangle

Participants

Dr Michael Forstner, Acino Pharma AG

TROUBLESHOOTING SESSION: Russia GMPrequirements


This extended interactive session providestheopportunity for attendees to ask questions andshare experiences related tolatest updates on RussianGMP requirements.

Participants

Anna Zamakhaeva, Galderma, Russia

Understanding the regulatory framework forregistration in Mexico


• Assessing the current regulatory environment andany recent or upcoming changes

• Clarifying the structure and activities of the NewMolecule Committee (NMC) and any upcomingchanges

• Outlining the need to repeat tests in Mexico as partof import testing and whether any exemptions aremade

• Comparing regulatory requirements in Mexico toEurope

Participants

Simone Granchi, Menarini Ricerche S.p.A., Italy

Practically implementing the mandatory use ofelectronic application forms (eAF) for allmedicines licensing procedure types


• Outlining latest progress, timelines and objectivesof eAF

• Discussing experiences and lessons learnt so farwith use of eAF for all medicines licensingprocedure types, including national procedures

• Overcoming key challenges faced so far withmandatory eAF use

• Outlining how eAF are performing to date includingany difficulties with opening and lengthy load uptimes

Participants

Karen Wittkopf, Boehringer Ingelheim GmbH & Co. KG,Ingelheim, Germany

Question and answer session


Networking and morning coffee


Assessing how drug interchangeability isdefined and established according toamendments introduced by Federal Law No.429-FZ


• Determining how the amendments introduce anddefine drug interchangeability

• Understanding how establishing a procedure fordetermining interchangeability will impact industry

• Exploring the criteria that must be covered in orderfor pharmaceuticals to be deemed interchangeable

Participants

Edelgard Rehak, Dr. Edelgard Rehak Consulting,Germany

Exploring the new regulation for variations inBrazil and third party reviews and therecognition model in Mexico


• Key concepts from the new regulation forvariations in Brazil and impact on industry

• Understanding how third party reviews and therecognition model in Mexico has resulted in areduction of approval times for certain products

Participants

Antonio Trejo Diaz, TEVA, USA

Latest updates and progress with the SingleSubmission Portal: The use of CESP and EMAGateway


• Assessing latest updates and timelines for a SingleSubmission Portal

• Understanding the impact a Single SubmissionPortal would have on industry and changes inprocedures

• Addressing concerns of integrating CESP with theEMA Gateway and whether more resources andtime will be required

• Determining how the current situation can beimproved and an ideal model for how it would work

• Regulatory agency perspectives and feedback

Participants

Karen Wittkopf, Boehringer Ingelheim GmbH & Co. KG,Ingelheim, Germany

Examining the latest updates from PRAC


• Assessing current pharmacovigilance legislationand clarifying key changes for industry

• Applying recommendations from PRAC to improvelabelling practices

• Clarifying evaluation of new adverse reactions• Examining the extent to which PRAC updates are

increasing and clarifying timelines for updates

Speaker to be confirmed




Berlin


FLASH UPDATE: Implementing the RussianCTD format for registration dossiers underamendments introduced by the Federal LawNo. 429-FZ


• Assessing the upcoming requirement for theRussian CTD format and timelines forimplementation

• Outlining key challenges that industry will facefollowing the CTD format

• Determining how these challenges can beovercome

Participants

Anna Harrington Morozova, Regem Consulting

Navigating the regulatory framework forregistration in Chile


• Outlining the current regulatory environment andany recent or upcoming changes

• Case examples of successful registration in Chile• Reviewing documentation requirements and

timelines• Overcoming key regulatory challenges

Participants

Cathie Gongora, Sanofi Pasteur, France

Practically implementing strategies for eCTDonly DCP, MRP and National Proceduresubmissions


• Clarifying the objectives and timelines involvedwith eCTD only DCP, MRP and National Proceduresubmissions

• Sharing experiences and lessons learnt so far:What has the impact been on resources?

• Practically preparing and organising work formandatory eCTD format for National procedures by2018

• Outlining key pitfalls and challenges seen so farand how these have been overcome

Participants

Maike Diepen-Engisch, Teva, Germany

Practically meeting the authority expectationsregarding PRAC implementation timelines


• Clarifying what authorities are looking for regardingdecision making and labelling changes

• The PRAC referral procedure regarding safetyconcerns

• Analysing the importance of interaction with PRACduring the evaluation of an issue

• Strategies for keeping to proposed deadlineswithout violating Good Vigilance Practice andcompany SOPs

• Balancing regulatory compliance and keeping toauthority timelines with providing timely andaccurate information

Participants

Simon Ashworth , Takeda Development Centre EuropeLtd.

Quickfire Q&A Session


Led by speakers from the session

Networking lunch


Latest regulatory updates in Ukraine includingthe recently adopted Ministry of Health’s OrderNo 452 which came into force September 2015


• Clarifying the status and timelines of the Ministryof Health’s Order No 452 since it entered into forceon 18 September 2015

• Determining key impacts of the Ministry of Health’sOrder No 452 on industry

• Outlining requirements for GMP compliance inUkraine and how the Ministry of Health’s Order No452 will impact this

• Reviewing the extent to which Ukraine is similar toEuropean regulations

Participants

Mariana Novozheniuk, Bayer Pharma AG, Germany

Evolving regulatory landscape in Latin America- comparison of regulatory requirements inChile, Brazil and Caribbean markets


• Exploring regulatory requirements in Chile, Braziland Caribbean markets

• Comparing how requirements differ

Participants

Rohit Kulkarni, Regulex Consulting Ltd., UK

Flash perspective: Industry perspective on thepractical use of the new PSUR repository


• Sharing experiences of use of the new PSURrepository so far

• Exploring the key challenges faced and how thesehave been overcome

• Assessing the advantages the PSUR Repositorybrings for regulatory authorities and industry

Participants

Chantal Le Floch, Servier, France

Regulatory feedback: Assessing the regulatorylandscape for pharmaceutical labelling


• Pharmacovigilance legislation and clarifying keychanges for industry

• Recommendations to improve labelling practices• Clarifying evaluation of new adverse reactions• Assessing current challenges for regulators

regarding pharmaceutical labelling




Berlin


THOUGHT EXCHANGE between the audienceand industry representatives


During this interactive session, regulatory authoritiesand industry experts will comment on their keyexperiences and challenges faced to date in EUTelematics. Attendees will then have the opportunityto ask questions and take part in group discussionaddressing some of the following topics:

• What have experiences been so far with the EUeCTD Module 1 Specification v3.0 and how has thisimpacted day-to-day work?

• What lessons have been learnt to date with use ofeAF for all medicines licensing procedure types,including national procedures?

• What impact will a Single Submission Portal haveon industry?

• What are the main concerns of integrating CESPand the EMA Gateway?

• What have experiences been so far with use of thePSUR repository?

• How have industry been implementing eCTD onlyDCP, MRP and National Procedure submissions todate?

Participants


Melanie Ruppel, Boehringer Ingelheim Pharma GmbH& Co. KG, Germany

Chantal Le Floch, Servier, France

Magda Andrițoiu, Alvogen, Romania

Maike Diepen-Engisch, Teva, Germany

EXTENDED Q&A SESSION: Sharingexperiences with registration in Ukraine andquestions on the latest regulatory updates


This extended Q&A discussion will provide attendeeswith an additional chance to get their questionsanswered and share experiences and challengesrelated to product registration in Ukraine.

• What key impacts of the Ministry of Health’s OrderNo 452 have been seen and experienced?

• What are some of the key challenges experiencedwhen registering products in Ukraine?

• How have these challenges been overcome?

Participants


Examining and implementingpharmacovigilance and risk managementactivities in Latin America


• Exploring which countries have increasingrequirements for pharmacovigilance

• Best practice for managing pharmacovigilanceactivities in Latin America

• Reviewing requirements in place for PSURs,tracking and reporting

• Clarifying requirements for Risk ManagementPlans in Latin America

• Outlining the degree to which Latin America hasaligned requirements to Europe and the US

Participants

Lisa Ruiz, AbbVie Inc., USA

Examining and implementingpharmacovigilance and risk managementactivities in Latin America


• Exploring which countries have increasingrequirements for pharmacovigilance

• Best practice for managing pharmacovigilanceactivities in Latin America

• Reviewing requirements in place for PSURs,tracking and reporting

• Clarifying requirements for Risk ManagementPlans in Latin America

• Outlining the degree to which Latin America hasaligned requirements to Europe and the US

Participants

Lisa Ruiz, AbbVie Inc., USA

Networking and afternoon tea


Exploring the regulatory framework and beststrategies for product registration inKazakhstan


• Current regulatory environment in Kazakhstan andany recent or upcoming changes

• Assessing the registration process and bestpractice for submitting a MAA

• Outlining Kazakhstan’s involvement in the EurasianUnion and impact on product registration

• Reviewing requirements for, and complying withGMP inspections in Kazakhstan

Participants


Regulatory requirements and challenges forbiosimilars registration in Latin America


• Assessing current regulatory requirements anddefinitions in place for biosimilars

• Region-specific requirements that are differentfrom EU/US

• Case examples of successful biosimilarsregistration in Latin America

• Focus on Brazil• Understanding expectations for ethnically relevant

clinical data for biosimilars

Participants

Thomas Kirchlechner, Sandoz GmbH, Austria

Latest update on EMA Policy 0070 onpublication and access to clinical trial data,and how this will impact Regulatory Operationsfunctions:


• Background to EMA Policy 0070• Assessing the latest status and timelines for

implementation• Understanding the EMA External Guidance• Redaction considerations, working with redactions

in PDF• Redaction proposals and final redactions in eCTD

format• Sharing experiences, concerns and challenges to

date

Participants





Berlin


The Need for Quality Management and ProcessControl in a Pharma Artwork Studio


• Reviewing the benefits of a QMS in a GMP artworkstudio

• Implementing a GMP compliant artwork process• Assessing Global Quality Standards to ensure

compliance• Identifying how Asset Management and Workflow

Technologies improve effectiveness• Controlling the artwork process to ensure

efficiency and transparency• Understanding The Customer/Vendor relationship

to improve collaboration

Participants

Suzanne Ivory , Perigord

Latest updates and practical experiences withthe Eurasian Union


• Current status of the Eurasian Union following the1 January 2016 date of coming into force

• Examining expectations for a common procedureof registration and dossier format

• Understanding how the Eurasian Union will work inpractice including when European documents canbe used and additional requirements

• Exploring the extent to which the Eurasian Union issimilar to the European Union

Participants

Galina Senchukova, Sanofi Pasteur Eurasia, Russia

LATAM COLLABORATION ZONE


Round table 1: Brazil

Round table 2: Chile

Round table 3: Adapting to requirements in emergingmarkets focusing on LATAM

Round table 4: Comparison of regulatory requirementsin Chile, Brazil and Caribbean markets

Participants


Cathie Gongora, Sanofi Pasteur, France

Andrea Herrmann, Merck KGaA, Germany

Rohit Kulkarni, Regulex Consulting Ltd., UK

Regulatory agency perspective: Feedback,plans and practical advice for eCTDsubmissions


• Outlining current agency priorities and future plans• Exploring where focus has been made on the EU

eSubmissions Roadmap• Reviewing expectations and requirements for

industry eCTD submissions• Feedback on common errors and observations

from eCTD submissions• Assessing agency readiness for mandatory eCTD

and the adoption of eCTD v4.0

Participants

Triin Mäesalu, State Agency of Medicines, Estonia

Managing the end to end labelling process:optimising internal processes and oversight forefficient and compliant labelling


• Creating a robust and reliable system to monitorlabel modifications and changes globally

• Tracking deviations from a global perspective:strategies to ensure oversight over the entireprocess

• Ensuring quality control of labelling content andartworks

• Balancing the need to get information out quicklyand complying from a regulatory standpoint

• Bundling labelling updates to drive up efficiencies

Participants

Lynsey Flitton, AbbVie

Navigating regulatory requirements andexploring successful marketing strategies forbiosimilars in Russia and CIS countries


• Exploring current regulatory requirements in placefor biosimilars

• Reviewing the criteria for biosimilarity and howsimilar a product must be to be considered abiosimilar

• Understanding expectations for extrapolatingindications for biosimilars

• Best practice for successful biosimilarsregistration and marketing strategies in Russia andCIS countries

• Case examples of commercial successes

Participants

Roman Ivanov, BIOCAD, Russia

Building a regulatory publishing team anddefining processes for electronic submissions


• Successfully building a regulatory publishing team• Ensuring processes for electronic submissions are

defined

Participants

Magda Andrițoiu, Alvogen, Romania

End of conference day one and networkingdrinks





Berlin


TIME MAIN AGENDA EMERGING MARKETS STREAM1: RUSSIA, CIS, TURKEY,MIDDLE EAST & AFRICA

EMERGING MARKETS STREAM2: LATIN AMERICA & ASIA-PACIFIC

GLOBAL ESUBMISSIONS PHARMACEUTICAL LABELLING

08:00 08:00 - Registration

09:00 09:00 - Opening remarks from theChairperson

09:10 - Overview of Russian Nationaland EEU registration process

09:45 - Exploring the new andupcoming Russian GMP inspectionrequirements for foreign drugs

09:10 - Exploring the latest regulatoryenvironment in Brazil and beststrategies for product registration

09:45 - Brazil extended session

09:10 - Flash update: The EUeSubmissions Roadmap - what isupcoming, timelines and impact onindustry?

09:25 - EXTENDED ROUND TABLESSESSION: Update and experienceswith EU eCTD Module 1 Specificationv3.0 becoming mandatory from 1stOctober 2016

09:10 - Interactive discussionsession: Improving communicationbetween pharmacovigilance,labelling, regulatory affairs and riskmanagement to ensure compliant,relevant and timely labelling updates

10:00 10:45 - Question and answer session

10:55 - Networking and morningcoffee

10:20 - TROUBLESHOOTINGSESSION: Russia GMP requirements

10:20 - Understanding the regulatoryframework for registration in Mexico

10:20 - Practically implementing themandatory use of electronicapplication forms (eAF) for allmedicines licensing procedure types

10:10 - Risk minimisation: Examiningstrategies to reduce medicationerrors through effective labelling

11:00 11:25 - Assessing how druginterchangeability is defined andestablished according toamendments introduced by FederalLaw No. 429-FZ

11:25 - Exploring the new regulationfor variations in Brazil and third partyreviews and the recognition model inMexico

11:25 - Latest updates and progresswith the Single Submission Portal:The use of CESP and EMA Gateway

11:25 - Examining the latest updatesfrom PRAC

12:00 12:35 - Networking lunch 12:00 - FLASH UPDATE:Implementing the Russian CTDformat for registration dossiers underamendments introduced by theFederal Law No. 429-FZ

12:15 - Quickfire Q&A Session

12:00 - Navigating the regulatoryframework for registration in Chile

12:00 - Practically implementingstrategies for eCTD only DCP, MRPand National Procedure submissions

12:00 - Practically meeting theauthority expectations regardingPRAC implementation timelines

13:00

SCHEDULEREG AFFAIRS IN EMERGING MARKETS, ESUBMISSIONS & PHARMA LABELLING DAY 1 - 18/10/2016


Berlin





14:00 14:00 - Latest regulatory updates inUkraine including the recentlyadopted Ministry of Health’s Order No452 which came into forceSeptember 2015

14:35 - EXTENDED Q&A SESSION:Sharing experiences with registrationin Ukraine and questions on the latestregulatory updates

14:00 - Evolving regulatory landscapein Latin America - comparison ofregulatory requirements in Chile,Brazil and Caribbean markets

14:35 - Examining and implementingpharmacovigilance and riskmanagement activities in LatinAmerica

14:00 - Flash perspective: Industryperspective on the practical use ofthe new PSUR repository

14:15 - THOUGHT EXCHANGEbetween the audience and industryrepresentatives

14:00 - Regulatory feedback:Assessing the regulatory landscapefor pharmaceutical labelling

14:35 - Examining and implementingpharmacovigilance and riskmanagement activities in LatinAmerica

15:00 15:10 - Networking and afternoon tea 15:40 - Exploring the regulatoryframework and best strategies forproduct registration in Kazakhstan

15:40 - Regulatory requirements andchallenges for biosimilarsregistration in Latin America

15:40 - Latest update on EMA Policy0070 on publication and access toclinical trial data, and how this willimpact Regulatory Operationsfunctions:

15:40 - The Need for QualityManagement and Process Control ina Pharma Artwork Studio

16:00 16:15 - Latest updates and practicalexperiences with the Eurasian Union

16:50 - Navigating regulatoryrequirements and exploringsuccessful marketing strategies forbiosimilars in Russia and CIScountries

16:15 - LATAM COLLABORATIONZONE

16:15 - Regulatory agencyperspective: Feedback, plans andpractical advice for eCTDsubmissions

16:50 - Building a regulatorypublishing team and definingprocesses for electronic submissions

16:15 - Managing the end to endlabelling process: optimising internalprocesses and oversight for efficientand compliant labelling

17:00 17:25 - End of conference day oneand networking drinks



Berlin




Case study: Best practice for normativedocument preparation


• Clarifying what needs to be included in thenormative document

• Overcoming the challenges of sample andstandard importation

• Reviewing the relationship between CTD formatand the normative document

• Outlining the importance of communicating withlocal affiliates to ensure the process is transparent

• Examining the pros and cons of working with aCRO for normative document preparation

Participants

Anna Litsiou, Astellas, The Netherlands

Product registration and latest regulatoryupdates in China: Challenges and opportunities


• · Exploring recent and upcoming changes to theregulatory environment in China

• · Outlining how changes to regulatory requirementsare impacting industry

• · Examining exactly what is required for MAAsubmissions, variations and renewals

• · Overcoming tight deadlines for compliance withlocal pharmacopeia

• · Reviewing whether China leans more towardsEurope or US-like requirements

Participants

Joe Zhou, Genor BioPharma, China

Ministry of Health perspective: Latest updatesand progress for eCTD submissions in Oman


• Outlining plans, guidance and timelines for eCTD inOman

• Addressing pilot project findings and outcomes• Examining the technical specification and

validation criteria for eCTD submissions in Oman• Sharing practical advice for migrating from EU or

US eCTD to Oman• Highlighting the remaining challenges for the

implementation of eCTD in Oman

Participants

Mohanned El Khider, Ministry of Health, Oman

Industry case study: Practically Implementinglabelling updates to achieve global levelapproval


• Assessing the challenges and opportunities ofcountry-specific labelling and localisation oflabelling

• Understanding what local labelling is based on/country dependencies/country of origin

• Understanding how to effectively track labellingamendments globally

• Strategies for adding a new adverse event onto thelabel and overcoming the challenge of workingwith different timelines

• Improving cooperation and communicationbetween headquarters and affiliates

• Examining key differences between the US and EU•

Participants

Bas Van Heijst,, Astellas

Practically conducting clinical trials in Russiaand the impact of separating clinical trials fromregistration procedures under Federal Law No.429-FZ


Participants


China extended session


Attendeeswill be split into small groups for aninteractive discussion allowing them toshareexperiences with product registration and solutions tocommon problems inChina with other attendees.

Participants


Kamani Gopalakrishna , Boehringer Ingelheim PharmaGmbH & Co. KG, Germany

Ching Li, Biotest Pharma GmbH, Germany

Assessing the importance of translation andreadability when updating labelling globally


• Managing the differences and overcoming versioncontrol issues

• Human Factors vs. User-testing: Meeting EU andUS readability requirements

• Global, ‘common’ package leaflets: Rationale forcreation. Strategies for dealing with Globalrequirements

• Dependent markets: Relevance of ‘lead’ countryLegislation and Guidelines for the Dependentmarket

Participants

Paul Soul-Williams, AbbVie

Saudi FDA perspective: Latest updates andprogress for eCTD submissions in Saudi Arabia


• Reviewing plans, timelines for eCTD in SaudiArabia and any guidance available

• Practical advice for successful eCTD submissionsin Saudi Arabia

• Assessing the eCTD implementation challenges inSaudi Arabia

Participants

Abdullah Abdulaziz Alduraibi, Saudi FDA, Saudi Arabia

Latest updates and progress for eSubmissionsin Jordan


• Examining plans, timelines for eCTD in Jordan &any guidance available

• eSubmission and tracking system in Jordan• Exploring the remaining challenges for the

implementation of eCTD in Jordan

Participants

Wesal Haqaish, Jordan FDA, Jordan

Clinical trials of medicines: Current regulatoryenvironment and updated local regulations inUkraine


Participants

Nataliia Bogdan, Independent Speaker (previously –Central Regulatory Authority), Ukraine




Berlin


Case study: Best strategies for successfulproduct registration in India


• Case examples of successful product registrationin India

• Understanding exactly what is required for MAAsubmissions, variations and renewals in India

• Reviewing and managing submission timelines inIndia

• Overcoming key regulatory challenges experienced

Participants


Pharmaceutical Labelling presentationdelivered by Schlafender Hase




Examining latest updates and sharingexperiences with submitting eCTD in Australia


• Current status, agency updates and timelines foreCTD in Australia

• Assessing key findings and expectations from theTGA

• Successfully submitting to the regulatory agency• Sharing experiences from AU eCTD submissions

and comparing with EU eCTD submissions

Participants

Nathalie Mueller-Andriamboavonjy, Incyte, Switzerland

INTERACTIVE ROUNDTABLES: Sharingexperiences with conducting local clinicaltrials in Russia and CIS


• Sharing experiences with implementing therequirements in place for local clinical trials

• Success stories with conducting local clinical trials• What challenges and pitfalls have been seen with

local clinical trials?• How have these challenges been overcome?

Participants

Alex Dranov, Dr. Willmar Schwabe, GmbH & Co. KG,Germany


Exploring the regulatory framework andconsiderations for successful productregistration in South Korea


• Current regulatory environment in South Korea andany upcoming changes

• Determining what is required for MAA submissions

Participants

Eric Ducamp, Ipsen, France

Panel discussion: Overcoming the challengesof implementing global level updates -improving communication and cooperation


• Assessing strategies to improve communicationbetween internal teams to ensure a streamlinedapproach to global labelling

• Understanding the importance of culturaldifferences when communicating withheadquarters and affiliates

• Managing the end to end labelling process on aglobal level

Speakers from the morning session

China: Latest updates and sharing experienceswith submitting eCTD


• Assessing plans for eCTD in China and anyguidance available

• Discussing the timelines for eCTD implementationin China

• Exploring the remaining challenges for theimplementation of eCTD in China

• Comparing requirements and expectations inChina with EU eCTD submissions

Participants

Carolline Petersen, Novo Nordisk A/S, Denmark

Reviewing labelling requirements andovercoming challenges in Russia and the CISmarkets


• Exploring requirements in place for labelling inRussia and CIS countries

• Overcoming key labelling challenges

Participants

Giovanna Ferrari, Pfizer, UK

Clarifying Taiwan’s regulatory framework andpractical advice for product registration


• Current regulatory environment in Taiwan and anyupcoming changes

• Determining what is required for MAA submissions• Overcoming key regulatory pitfalls experienced in

Taiwan

Participants

Cécile Vareilles, Ipsen, France

Reviewing labelling requirements andovercoming challenges in Russia and the CISmarkets


• Exploring requirements in place for labelling inRussia and CIS countries

• Overcoming key labelling challenges

Participants

Giovanna Ferrari, Pfizer, UK




Berlin


Networking lunch


Examining the current status of the FalsifiedMedicines Directive and the current challengesbeing faced by industry


• Short assessment FMD+DR• NMVO foundation• NMVS implementation• Lessons learned

Participants

Johan Verhaeghe, Medicines for Europe

RUSSIA AND CIS COLLABORATION ZONE


Save your questions from the session and join a roundtable dedicated to your region of choice. Join thespeaker and other attendees as they shareexperiences on the challenges faced in a highlyinteractive environment.

Round table 1: Russia

Round table 2: Ukraine

Round table 3: Kazakhstan

Round table 4: Eurasian Union

Participants

Alex Dranov, Dr. Willmar Schwabe, GmbH & Co. KG,Germany

Edelgard Rehak, Dr. Edelgard Rehak Consulting,Germany



Galina Senchukova, Sanofi Pasteur Eurasia, Russia

Reviewing latest regulatory progress in theASEAN countries and impact on industry


• Outlining key recent regulatory updates from theASEAN countries and harmonisation efforts

• Evaluating the status of the ACTD format andupdates on harmonisation

• Overcoming the challenge of different agencyrequirements including expectations for stabilitydata

Participants

Inês Pinto, Actelion Pharmaceuticals Ltd., Portugal

Examining the latest progress towards eCTDsubmissions in Thailand


• Latest changes to the Mod1 specifications• Lessons learned• Setting example for ASEAN region?

Participants

Jens Pantke, F. Hoffmann-La Roche Ltd. Switzerland

Case study: Successful product registrationand latest regulatory requirements in Japan


• Examining latest regulatory requirements andupdates in Japan

• Understanding the registration milestones• Outlining local clinical trial requirements• Reviewing similarities with regulatory pathways

and timelines to Europe and the US

Participants

Lamine Messaoudi, International Regulatory ConsultGroup, USA

Spotlight Presentation -Please contactAlexander Zenonos for more information:[email protected] or call +44(0) 20 701 77742


Outlining latest updates on the new US Module1 v2.3 and practical implications for industry


• Reviewing latest updates from the FDA andtimelines for mandatory use of the new version

• Practical advice for complying with US Module 1v2.3 and eCTD Validation Criteria v3.1requirements

• Overcoming practical challenges presented by USModule 1 v2.3 and eCTD Validation Criteria v3.1

• Understanding how FDA requests for eCTDsubmissions compare to Europe and keydifferences

Participants

Olga Alfieri, Eisai, USA



Serialisation workshop: Examining strategiesto overcome labelling challenges resultingfrom increasing serialisation and codingrequirements


• An overview of the Falsified Medicines Directive:how will this impact serialisation requirements?

• Highlighting Commission Delegated Regulation(EU) 2016/161

• Assessing different ways of implementingserialisation on products

• Examining serialisation requirements around theglobe

• Serialisation in the US: examining the status so farand understanding the lessons learnt - Avastin

Participants

Horst Kastrup, MEDA Pharma GmbH & Co. KG




Berlin


Implementing a revised ICH GCP in EmergingMarkets: Developing EU & FDA RiskManagement Plans Appropriate to EmergingMarkets

15:40 - 16:15Emerging Markets PLENARY SESSION

• Developing a systematic approach to riskmanagement for medicinal products developedacross regulatory regions

• The ICH revision and the importance of EU andFDA guidances for emerging markets

• Specific approaches to evaluating proportionaterisk in emergingmarkets

• The role of the sponsor and the role of the CRO inRisk Based Monitoring in emerging markets

• A perspective-based approach to risk managementin implementing and monitoring clinical trials inemerging markets

Participants

Francis P. Crawley, Good Clinical Practice Alliance –Europe (GCPA), Belgium

Presentation to be delivered by NNIT


Health agency interactions in emergingmarkets across the globe; availablepossibilities, timings of advice and its impacton overall regulatory strategy


• Mandatory vs optional health agency interactions• Different options available to get advice• How to prepare – role of local affiliates• Regional / local cultural aspects to be considered

Participants

Ayaz Khan, Grünenthal GmbH, Germany

GLOBAL eSUBMISSIONS COLLABORATIONZONE


Save your questions from the session and join a roundtable dedicated to your region of choice. Join thespeaker and other attendees as they shareexperiences on the challenges faced in a highlyinteractive environment.

Participants


Mohanned El Khider, Ministry of Health, Oman

Nathalie Mueller-Andriamboavonjy, Incyte, Switzerland

Jens Pantke, F. Hoffmann-La Roche Ltd. Switzerland

Carolline Petersen, Novo Nordisk A/S, Denmark

Out of industry perspective: Developing acommon corporate culture across establishedand emerging markets


• Corporate culture: what is it and how do we share itthroughout the company and with affiliates?

• Developing communication strategies forimplementing and sharing a risk-based approachto clinical trials

• Achieving a culture of science and a culture ofethics within a robustbusiness model

• Breaking down silos and implementing asuccessful information transfer system acrosscorporate groups and with affiliates

Participants

Chie Misumi, Intercultural Communication Specialist

Case study: Successfully outsourcingregulatory publishing and overcoming keychallenges – one year on


• Sharing practical experiences with outsourcing andthe pros and cons

• Identifying which activities should be outsourcedand which should be retained in house

• Insourcing versus outsourcing• Ensuring organisational structure and roles

successfully accommodate the chosen sourcingmodel

Participants

Richard Knowles, Ipsen Biopharm Limited, UK

End of conference day two





Berlin


TIME MAIN AGENDA EMERGING MARKETSPLENARY SESSION

EMERGING MARKETSSTREAM 1: RUSSIA, CIS,TURKEY, MIDDLE EAST &AFRICA

EMERGING MARKETSSTREAM 2: LATINAMERICA & ASIA-PACIFIC

GLOBAL ESUBMISSIONS PHARMACEUTICALLABELLING

09:00 09:00 - Opening remarks fromthe Chairperson

09:10 - Case study: Bestpractice for normativedocument preparation

09:45 - Practically conductingclinical trials in Russia and theimpact of separating clinicaltrials from registrationprocedures under Federal LawNo. 429-FZ

09:10 - Product registrationand latest regulatory updatesin China: Challenges andopportunities

09:45 - China extendedsession

09:10 - Ministry of Healthperspective: Latest updatesand progress for eCTDsubmissions in Oman

09:45 - Saudi FDA perspective:Latest updates and progressfor eCTD submissions in SaudiArabia

09:10 - Industry case study:Practically Implementinglabelling updates to achieveglobal level approval

09:45 - Assessing theimportance of translation andreadability when updatinglabelling globally

10:00 10:55 - Networking andmorning coffee

10:20 - Clinical trials ofmedicines: Current regulatoryenvironment and updated localregulations in Ukraine

10:20 - Case study: Beststrategies for successfulproduct registration in India

10:20 - Latest updates andprogress for eSubmissions inJordan

10:50 - PharmaceuticalLabelling presentationdelivered by Schlafender Hase

11:00 11:25 - INTERACTIVEROUNDTABLES: Sharingexperiences with conductinglocal clinical trials in Russiaand CIS

11:25 - Exploring theregulatory framework andconsiderations for successfulproduct registration in SouthKorea

11:25 - Examining latestupdates and sharingexperiences with submittingeCTD in Australia

11:25 - Panel discussion:Overcoming the challenges ofimplementing global levelupdates - improvingcommunication andcooperation

12:00 12:35 - Networking lunch 12:00 - Reviewing labellingrequirements and overcomingchallenges in Russia and theCIS markets

12:00 - Clarifying Taiwan’sregulatory framework andpractical advice for productregistration

12:00 - China: Latest updatesand sharing experiences withsubmitting eCTD

12:00 - Reviewing labellingrequirements and overcomingchallenges in Russia and theCIS markets

13:00



Berlin






14:00 14:00 - RUSSIA AND CISCOLLABORATION ZONE

14:00 - Reviewing latestregulatory progress in theASEAN countries and impacton industry

14:35 - Case study: Successfulproduct registration and latestregulatory requirements inJapan

14:00 - Examining the latestprogress towards eCTDsubmissions in Thailand

14:35 - Outlining latestupdates on the new USModule 1 v2.3 and practicalimplications for industry

14:00 - Examining the currentstatus of the FalsifiedMedicines Directive and thecurrent challenges being facedby industry

14:35 - Spotlight Presentation-Please contact AlexanderZenonos for more information:[email protected] call +44 (0) 20 701 77742

15:00 15:10 - Networking andafternoon tea

15:40 - Implementing a revisedICH GCP in Emerging Markets:Developing EU & FDA RiskManagement PlansAppropriate to EmergingMarkets

15:40 - Presentation to bedelivered by NNIT

15:40 - Serialisation workshop:Examining strategies toovercome labelling challengesresulting from increasingserialisation and codingrequirements

16:00 16:15 - Health agencyinteractions in emergingmarkets across the globe;available possibilities, timingsof advice and its impact onoverall regulatory strategy

16:50 - Out of industryperspective: Developing acommon corporate cultureacross established andemerging markets

16:15 - GLOBALeSUBMISSIONSCOLLABORATION ZONE



Berlin






17:00 17:25 - End of conference daytwo

17:25 - Case study:Successfully outsourcingregulatory publishing andovercoming key challenges –one year on



Berlin




WORKSHOP: Best practices for creating aCCDS suitable for global implementation


• Examining possible approaches to the structureand content of a CCDS

• Understanding commonalities and differences inlabelling requirements

• Managing creation of CCDS content andassignment of reference safety information

• Defining principles for implementation of CCDSinto local labelling

• Creating adequate documentation to supportsubmission of new or updated labelling to healthauthorities

Participants

Barbara Lachmann, Lachmann Consulting

Practical advice for product registration andregulatory updates from the Gulf CooperationCouncil (GCC)


• Reviewing the current regulatory environment inSaudi Arabia, Oman and the UAE

• Current regulatory updates and product registrationin Oman

• Outlining requirements for filing variations in theGCC

• Practical advice when registering in the GCCregion, including documentation requirements andtimelines

• Clarifying the current status of the centralisedregistration procedure in the GCC and overview ofhow it works

Participants

Abid Hussain, Saudi Pharmaceutical Industries – SPI,Saudi Arabia

Working globally and adapting to requirementsin emerging markets with a focus on LatinAmerica


• Sharing strategies for working globally andadapting to emerging market requirements

• Focusing on Latin America

Participants

Andrea Herrmann, Merck KGaA, Germany

Understanding the updated EMA timelines forIDMP Iteration 1 and impact of a phasedimplementation approach on industry


• Clarifying the current status and timelinesassociated with:

• Publication of EU Implementation Guides• Start of implementation of Iteration 1 for products

and substances• Enforcement of Iteration 1 for products and

substances• Assessing the scope of Iterations 1, 2, 3 and 4 and

the impact a phased approach will have on industry• Reviewing latest priorities and updates from the

EMA

Participants

Andrew P Marr, Marr Consultancy Ltd., UK

Latest regulatory updates and practicallyregistering in Jordan


• Reviewing the latest regulatory requirements andany recent updates

• Registering in Jordan, including documentationrequirements and timelines

• Outlining requirements for filing variations inJordan

• Understanding the degree of alignment toEuropean regulations

• Overcoming key regulatory challenges

Participants

Syndie Messager, Laboratorios Cinfa

Ensuring specific stability data requirementsare met in Latin America


• Outlining the specific dossier requirements forstability data in Latin America

• Case examples of stability data requested andprovided

• Overcoming challenges with specific stabilityrequirements and long timelines for studies

Participants

Meike Vanhooren, Pfizer, Germany

FDA perspective: Update on the GSRS and itsuse at FDA


Participants

Larry Callahan, FDA, USA

Reviewing current Africa regulatoryharmonisation initiatives and practical adviceon product registration


• Understanding latest harmonisation initiatives forregulatory requirements across Africa

• Key considerations for submission includingdocumentation requirements and how these varybetween different countries/regions.

• Collaborative registration procedure based on theapproval of a Stringent Regulatory Authority (SRA) -Experience from pilot of Janssen drugs in severalAfrican countries.

Participants

Mercè Caturla, Janssen Pharmaceutica N.V., Belgium

Reviewing labelling and packagingrequirements and overcoming challenges inAsia-Pacific


• Understanding the requirements for labelling andpackaging in Asia-Pacific

• Examining the use of multi-language labelling andpackaging in Asia-Pacific

• Successfully using standard export packageinserts

• Overcoming key challenges

Participants





Berlin


Presentation to be delivered by AMPLEXOR




Overcoming challenges for successful productregistration in South Africa


• Current regulatory environment in South Africa andany upcoming or recent changes

• Best strategies for registering in South Africaincluding managing the long timelines involvedwith the approval process

• Overcoming the challenge of long approvaltimelines for registration of different productstrengths or forms

• Latest update on eCTD implementation in SouthAfrica and the 1 June 2016 deadline

• Outlining the extent to which submissions in SouthAfrica are similar to the European style

Participants

Merle Scher, Merck, South Africa

ASIA-PACIFIC COLLABORATION ZONE


Round table 1: China

Round table 2: India

Round table 3: South Korea

Round table 4: Taiwan

Round table 5: ASEAN countries

Participants


Alan Chalmers, Pharma International, Switzerland


Eric Ducamp, Ipsen, France

Cécile Vareilles, Ipsen, France

Inês Pinto, Actelion Pharmaceuticals Ltd., Portugal

Flash presentation: Case study – successfullypreparing for IDMP implementationirrespective of the delay


• Discussing the strategy taken with the IDMPproject following the updated EMA timelines

• Examining how the updated IDMP timelines can beleveraged to improve business operations

• Outlining any adjustments which were made andhow these were carried out

• Understanding the importance of steps that can betaken at this stage to ensure preparation andreadiness for a phased implementation approach

• Exploring whether any funding or staffing has beenscaled down and which parts of the project havebeen kept going

WORKSHOP: PART TWO: Best practices forcreating a CCDS suitable for globalimplementation


• Examining possible approaches to the structureand content of a CCDS

• Understanding commonalities and differences inlabelling requirements

• Managing creation of CCDS content andassignment of reference safety information

• Defining principles for implementation of CCDSinto local labelling

• Creating adequate documentation to supportsubmission of new or updated labelling to healthauthorities

Participants

Barbara Lachmann, Lachmann Consulting








Participants

Quentin Grignet, GSK, Belgium

Outlining the regulatory framework in NorthAfrica and practical advice for market entry


• Assessing the current regulatory environment inNorth Africa and any recent or upcoming changes

• Exploring key considerations for submissionincluding documentation requirements andtimelines

• Successfully providing registration samples soauthorities can reproduce analytical methods used

• Overcoming other key regulatory challenges

Participants

Abdul Mateen, AstraZeneca, UK








Participants

Costas Mistrellides, Regulatory Affairs Executive, UK

Company Core Data Sheet Industry case study





Berlin


Flash presentation: Case study –understanding how the updated IDMPtimelines can be leveraged to improvebusiness operations


• Outlining the strategy taken with the IDMP projectfollowing the updated EMA timelines

• Exploring how the updated IDMP timelines can beleveraged to improve business operations

• Reviewing any adjustments which were made andhow these were carried out

• Highlighting the importance of steps that can betaken at this stage to ensure preparation andreadiness for a phased implementation approach

• Discussing whether any funding or staffing hasbeen scaled down and which parts of the projecthave been kept going

Participants

Jakob Juul Rasmussen, Independent Consultant,Denmark

Networking lunch


Case study: Overcoming the challenge of GMPinspections in Turkey


• Understanding the regulatory guidance availablefor GMP site audits

• Addressing the long timelines involved with GMPsite audits and how long it takes to get approvalafterwards

• Exploring the documentation which must beprepared for GMP site audits and other specificrequirements

• Reviewing whether and when procedures for GMPinspections in Turkey will change

Participants

Özdemir Şengören, UCB Pharma A.S., Turkey

Best practice for filing a variation and gainingapproval in Asia-Pacific


• Outlining key requirements for filing variations inAsia-Pacific

• Clarifying classification of variations and whetherthis is harmonised across countries in Asia-Pacific

• Exploring the timelines to get approval forvariations

• Overcoming the key challenges associated withfiling variations in Asia-Pacific

Participants

Judith Rupprecht, Mundipharma Research GmbH & CoKG, Germany

Flash case study – understanding how theupdated IDMP timelines can be leveraged toimprove business operations


• Outlining the strategy taken with the IDMP projectfollowing the updated EMA timelines

• Exploring how the updated IDMP timelines can beleveraged to improve business operations

• Reviewing any adjustments which were made andhow these were carried out

• Highlighting the importance of steps that can betaken at this stage to ensure preparation andreadiness for a phased implementation approach

• Discussing whether any funding or staffing hasbeen scaled down and which parts of the projecthave been kept going

Participants

Patrick Middag, Bristol-Myers Squibb, Belgium

Effective labelling as a tool for patient safety


• Why is effective labelling important? Safeguardingpatient safety

• Training patients on how to read labels• Educating patients on how to recognise side

effects and report to their doctor• The importance of patient -doctor communication• Collaboration between patient organisations and

the EMA• Collaboration between patient organisation and

companies• What needs to be done to improve the existing

situation?

Participants

Souzi Makri, EUPATI Fellow

Flash Case Studies Q&A Session


Joined by speakers from the session

Exploring local manufacturing in the GCC as anopportunity for faster generics registration


• Current status of local manufacturing in the GCC• Understanding how this impacts generics

registration

Participants

Ibrahim Harb, Abbott, USA

Case study: Best practice for filing a variationand gaining approval in Asia-Pacific


• Reviewing best strategies for filing variations inAsia-Pacific

• Overcoming key challenges experienced

Participants


SME perspective: Understanding the strategiesand key challenges associated with getting anIDMP project started


• Exploring strategies and recommendations forgetting an IDMP project started

• Determining how the project was set up and wherethe company governance is located

• Spreading the understanding and implications ofIDMP to internal stakeholders

• Overcoming key challenges with starting an IDMPproject

Participants

Sue Metz, PAREXEL




Berlin


Examining the patient perspective: Improvingpharmaceutical labels


• Patient Information Leaflets: What should they looklike in an ideal world?

• Key recommendations for improving the PIL andexamining the implications for industry

• Ensuring PILs are as patient friendly as possible• Effectively conveying crucial & complex

information

Participants

Anne Lenihan, Pfizer



Exploring regulatory requirements forregistration of biosimilars in MENA


• Reviewing current regulatory requirements anddefinitions in place for biosimilars

• Examining the criteria for biosimilarity and howsimilar a product must be to be considered abiosimilar

• Case examples of successful biosimilarsregistration in MENA

• Exploring which regulatory pathways to take forproduct approval


Participants

Helmut Brunar, PassionBio – Creating Ventures,Austria

Evolving regulatory requirements for biosimilarregistrations in Asia-Pacific


• Exploring current regulatory requirements anddefinitions in place for biosimilars

• Examining the criteria for biosimilarity and howsimilar a product must be to be considered abiosimilar

• Best practice for successful biosimilarsregistration in Asia-Pacific

• Exploring which regulatory pathways to take forproduct approval


Participants

Rodeina Challand, Challand Biosimilar Consulting, UK

Case study: Practically implementing a MasterData Governance approach to overcome IDMPchallenges


• Assessing your current state• Establishing Internal Governance• Planning system related changes for improved

data management

Participants

Wil Foster, Eisai Limited, UK

Examining readability and usability of the PILand SmPC


• Evaluating current EU guidelines surrounding thePIL and SmPC

• Readability: assessing what information should bedisplayed and how it should be structured

• Examining the PIL and other mechanisms to getlabelling information to patients – getting accurateinformation to the end user in a language theyunderstand

Participants

Em Stevens, B.Braun Melsungen AG

Case study: Practical advice for successfulgenerics registration in MENA


• Case examples of successful generic productsregistration in MENA

• Examining successful documentation preparationfor generics

• Reviewing the timelines for obtaining approval• Stability study requirements for generics in MENA• Overcoming key regulatory pitfalls for registration

of generics

Participants

Anna Roznovska, PRO.MED.CS, Czech Republic

Latest updates and progress on controlledvocabularies for successful IDMPimplementation


• Understanding the importance of updatingcontrolled vocabularies for IDMP implementation

• Examining the current status of controlledvocabulary projects

• Exploring tools available to help map textual datawith IDMP’s controlled vocabularies

• Outlining key challenges faced and advice on howthese can be overcome

Participants

Andrew P Marr, Marr Consultancy Ltd., UK

An update on the EC report on readability ofthe SmPC


• Examining the current status of the report• Discussing implications for industry

Participants

Dominique Westphal, Paul Ehrlich Institute, Germany

Case study: Best practice for generic productregistration in Asia-Pacific


• Case examples of successful registration ofgeneric products in Asia-Pacific

• Examining the preparation of documents forgenerics

• Reviewing the timeline for getting approval forgenerics in Asia-Pacific

• Clarifying stability study requirements for generics

Participants

Pelin Boran, Pelin Boran Regulatory Affairs Solutions &Consultancy, Turkey

End of conference Stream 2 - please feel freeto move to Stream 1





Berlin


TURKEY AND MENA COLLABORATION ZONE


Round table 1: GCC

Round table 2: Jordan

Round table 3: Iran

Round table 4: Africa

Round table 5: Turkey

Participants

Abid Hussain, Saudi Pharmaceutical Industries – SPI,Saudi Arabia

Syndie Messager, Laboratorios Cinfa


Abdul Mateen, AstraZeneca, UK

Merle Scher, Merck, South Africa

Mercè Caturla, Janssen Pharmaceutica N.V., Belgium

Özdemir Şengören, UCB Pharma A.S., Turkey

Erhan Baş, Bilim Pharmaceuticals, Turkey

Tine Vermeulen, PLANPHARMA, Belgium

IDMP EXPERIENCE EXCHANGE ROUNDTABLES


In this interactive session, attendees will be split intosmall groups enabling them to share experiences andsolutions to common problems in an informalenvironment.

• How has the updated EMA timelines for IDMPimplementation impacted industry?

• Which parts of IDMP projects have companies keptgoing? Has any funding or staffing been scaleddown?

• To what extent is the delay being leveraged tooptimise business operations?

• Overcoming key challenges and concerns

End of conference





Berlin





09:00 09:00 - Opening remarks from theChairperson

09:10 - Practical advice for productregistration and regulatory updatesfrom the Gulf Cooperation Council(GCC)

09:45 - Latest regulatory updates andpractically registering in Jordan

09:10 - Working globally and adaptingto requirements in emerging marketswith a focus on Latin America

09:45 - Ensuring specific stabilitydata requirements are met in LatinAmerica

09:10 - Understanding the updatedEMA timelines for IDMP Iteration 1and impact of a phasedimplementation approach on industry

09:45 - FDA perspective: Update onthe GSRS and its use at FDA

09:10 - WORKSHOP: Best practicesfor creating a CCDS suitable forglobal implementation

10:00 10:55 - Networking and morningcoffee

10:20 - Reviewing current Africaregulatory harmonisation initiativesand practical advice on productregistration

10:20 - Reviewing labelling andpackaging requirements andovercoming challenges in Asia-Pacific

10:20 - Presentation to be deliveredby AMPLEXOR

11:00 11:25 - Overcoming challenges forsuccessful product registration inSouth Africa

11:25 - ASIA-PACIFICCOLLABORATION ZONE

11:25 - Flash presentation: Casestudy – successfully preparing forIDMP implementation irrespective ofthe delay


11:25 - WORKSHOP: PART TWO: Bestpractices for creating a CCDSsuitable for global implementation

12:00 12:35 - Networking lunch 12:00 - Outlining the regulatoryframework in North Africa andpractical advice for market entry


12:15 - Flash presentation: Casestudy – understanding how theupdated IDMP timelines can beleveraged to improve businessoperations

12:00 - Company Core Data SheetIndustry case study



Berlin





13:00

14:00 14:00 - Case study: Overcoming thechallenge of GMP inspections inTurkey

14:35 - Exploring local manufacturingin the GCC as an opportunity forfaster generics registration

14:00 - Best practice for filing avariation and gaining approval inAsia-Pacific

14:35 - Case study: Best practice forfiling a variation and gaining approvalin Asia-Pacific

14:00 - Flash case study –understanding how the updated IDMPtimelines can be leveraged toimprove business operations

14:15 - Flash Case Studies Q&ASession

14:35 - SME perspective:Understanding the strategies and keychallenges associated with getting anIDMP project started

14:00 - Effective labelling as a toolfor patient safety

14:35 - Examining the patientperspective: Improvingpharmaceutical labels

15:00 15:10 - Networking and afternoon tea 15:40 - Exploring regulatoryrequirements for registration ofbiosimilars in MENA

15:40 - Evolving regulatoryrequirements for biosimilarregistrations in Asia-Pacific

15:40 - Case study: Practicallyimplementing a Master DataGovernance approach to overcomeIDMP challenges

15:40 - Examining readability andusability of the PIL and SmPC

16:00 16:50 - End of conference Stream 2 -please feel free to move to Stream 1

16:15 - Case study: Practical advicefor successful generics registration inMENA

16:50 - TURKEY AND MENACOLLABORATION ZONE

16:15 - Case study: Best practice forgeneric product registration in Asia-Pacific

16:15 - Latest updates and progresson controlled vocabularies forsuccessful IDMP implementation

16:50 - IDMP EXPERIENCEEXCHANGE ROUND TABLES

16:15 - An update on the EC report onreadability of the SmPC

17:00

18:00 18:00 - End of conference



Berlin


Documents

SESSIONS Global Pharmaceutical Regulatory Affairs Summit · Global Pharmaceutical Regulatory Affairs Summit 18 ... Global Pharmaceutical Regulatory Affairs Summit 18 ... Menarini