Pre-Conference Evening Seminar: Implementing a Robust Strategy for Managing eSubmissions in a Diverse Global Environment 18:00 - 20:30 Global eSubmissions Topics to be discussed include: • Overview of the status of eSubmissions globally including which countries are accepting eCTD, other types of eSubmissions or paper • Reviewing whether the current degree of global harmonisation in submission requirements will improve • Best practice for managing global submissions in a synchronised and harmonised way • Understanding specific documentation requirements in different regions and how these can be created successfully and efficiently • Assessing varying expectations for submission content and format in different regions • Determining whether separate submissions must be made for the same registration in several regions, or whether one submission will suffice Participants Suzie Henderson, Takeda Development Centre Europe, UK Pre-Conference Evening Seminar: Best Practice for Conducting Multi-Regional Clinical Trials in the Emerging Markets 18:00 - 20:30 Emerging Markets Pre-Conference Evening Seminar Multi-regional clinical trials (MRCT) are now being conducted extensively in emerging markets with drug development being dramatically globalised in recent years. Despite the advantages that come with MRCT including faster development processes and shorter approval times, they do come with challenges. This interactive evening seminar will provide attendees with a comprehensive insight into optimal MRCT design and conduct. Topics to be discussed include: • Case examples of successful MRCT design and conduct • Understanding the key pros and cons of carrying out MRCTs • Examining how to design MRCTs that successfully address local population needs • Showing how MRCTs can reduce approval time and documentation requirements for clinical trial applications • Overcoming coming key challenges experienced when carrying out MRCT Participants Roger Joby, 1to1to1, UK SESSIONS PRE-CONFERENCE EVENING SEMINARS - 17/10/2016 Global Pharmaceutical Regulatory Affairs Summit 18 - 20 October 2016 Maritim proArte Hotel Berlin lifesciences.knect365.com/global-pharma-regulatory-affairs
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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
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
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
09:25 - 10:20Global eSubmissions
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
09:45 - 10:20Emerging Markets Stream 1: Russia, CIS, Turkey,Middle East & Africa
• 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
09:45 - 10:20Emerging Markets Stream 2: Latin America & Asia-Pacific
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.
• 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
10:20 - 10:55Emerging Markets Stream 1: Russia, CIS, Turkey,Middle East & Africa
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
10:20 - 10:55Emerging Markets Stream 2: Latin America & Asia-Pacific
• 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
10:20 - 10:55Global eSubmissions
• 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
THOUGHT EXCHANGE between the audienceand industry representatives
14:15 - 15:10Global eSubmissions
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
Alastair Nixon, GlaxoSmithKline Research &Development Limited, UK
EXTENDED Q&A SESSION: Sharingexperiences with registration in Ukraine andquestions on the latest regulatory updates
14:35 - 15:10Emerging Markets Stream 1: Russia, CIS, Turkey,Middle East & Africa
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
Mariana Novozheniuk, Bayer Pharma AG, Germany
Examining and implementingpharmacovigilance and risk managementactivities in Latin America
14:35 - 15:10Emerging Markets Stream 2: Latin America & Asia-Pacific
• 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
14:35 - 15:10Pharmaceutical Labelling
• 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
15:10 - 15:40Main agenda
Exploring the regulatory framework and beststrategies for product registration inKazakhstan
15:40 - 16:15Emerging Markets Stream 1: Russia, CIS, Turkey,Middle East & Africa
• 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
Anna Harrington Morozova, Regem Consulting
Regulatory requirements and challenges forbiosimilars registration in Latin America
15:40 - 16:15Emerging Markets Stream 2: Latin America & Asia-Pacific
• 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:
15:40 - 16:15Global eSubmissions
• 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
Alastair Nixon, GlaxoSmithKline Research &Development Limited, UK
SESSIONSREG AFFAIRS IN EMERGING MARKETS, ESUBMISSIONS & PHARMALABELLING DAY 1 - 18/10/2016
Case study: Best practice for normativedocument preparation
09:10 - 09:45Emerging Markets Stream 1: Russia, CIS, Turkey,Middle East & Africa
• 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
09:10 - 09:45Emerging Markets Stream 2: Latin America & Asia-Pacific
• · 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
09:10 - 09:45Global eSubmissions
• 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
09:10 - 09:45Pharmaceutical Labelling
• 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
09:45 - 10:20Emerging Markets Stream 1: Russia, CIS, Turkey,Middle East & Africa
Participants
Anna Litsiou, Astellas, The Netherlands
China extended session
09:45 - 10:20Emerging Markets Stream 2: Latin America & Asia-Pacific
Attendeeswill be split into small groups for aninteractive discussion allowing them toshareexperiences with product registration and solutions tocommon problems inChina with other attendees.
Examining the current status of the FalsifiedMedicines Directive and the current challengesbeing faced by industry
14:00 - 14:35Pharmaceutical Labelling
• Short assessment FMD+DR• NMVO foundation• NMVS implementation• Lessons learned
Participants
Johan Verhaeghe, Medicines for Europe
RUSSIA AND CIS COLLABORATION ZONE
14:00 - 15:10Emerging Markets Stream 1: Russia, CIS, Turkey,Middle East & Africa
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
Mariana Novozheniuk, Bayer Pharma AG, Germany
Anna Harrington Morozova, Regem Consulting
Galina Senchukova, Sanofi Pasteur Eurasia, Russia
Reviewing latest regulatory progress in theASEAN countries and impact on industry
14:00 - 14:35Emerging Markets Stream 2: Latin America & Asia-Pacific
• 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
14:00 - 14:35Global eSubmissions
• 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
14:35 - 15:10Emerging Markets Stream 2: Latin America & Asia-Pacific
• 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
14:35 - 15:05Pharmaceutical Labelling
Outlining latest updates on the new US Module1 v2.3 and practical implications for industry
14:35 - 15:10Global eSubmissions
• 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
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
15:40 - 16:15Global eSubmissions
Health agency interactions in emergingmarkets across the globe; availablepossibilities, timings of advice and its impacton overall regulatory strategy
16:15 - 16:50Emerging Markets PLENARY SESSION
• 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
16:15 - 17:25Global eSubmissions
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.
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
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
SCHEDULEREG AFFAIRS IN EMERGING MARKETS, ESUBMISSIONS & PHARMA LABELLING DAY 2 - 19/10/2016
Global Pharmaceutical Regulatory Affairs Summit18 - 20 October 2016Maritim proArte Hotel
WORKSHOP: Best practices for creating aCCDS suitable for global implementation
09:10 - 10:30Pharmaceutical Labelling
• 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)
09:10 - 09:45Emerging Markets Stream 1: Russia, CIS, Turkey,Middle East & Africa
• 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
09:10 - 09:45Emerging Markets Stream 2: Latin America & Asia-Pacific
• 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
09:10 - 09:45Global eSubmissions
• 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
09:45 - 10:20Emerging Markets Stream 1: Russia, CIS, Turkey,Middle East & Africa
• 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
09:45 - 10:20Emerging Markets Stream 2: Latin America & Asia-Pacific
• 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
09:45 - 10:20Global eSubmissions
Participants
Larry Callahan, FDA, USA
Reviewing current Africa regulatoryharmonisation initiatives and practical adviceon product registration
10:20 - 10:55Emerging Markets Stream 1: Russia, CIS, Turkey,Middle East & Africa
• 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.
Examining the patient perspective: Improvingpharmaceutical labels
14:35 - 15:10Pharmaceutical Labelling
• 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
Networking and afternoon tea
15:10 - 15:40Main agenda
Exploring regulatory requirements forregistration of biosimilars in MENA
15:40 - 16:15Emerging Markets Stream 1: Russia, CIS, Turkey,Middle East & Africa
• 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
• Understanding expectations for extrapolatingindications for biosimilars
Participants
Helmut Brunar, PassionBio – Creating Ventures,Austria
Evolving regulatory requirements for biosimilarregistrations in Asia-Pacific
15:40 - 16:15Emerging Markets Stream 2: Latin America & 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
• Understanding expectations for extrapolatingindications for biosimilars
Participants
Rodeina Challand, Challand Biosimilar Consulting, UK
Case study: Practically implementing a MasterData Governance approach to overcome IDMPchallenges
15:40 - 16:15Global eSubmissions
• 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
15:40 - 16:15Pharmaceutical Labelling
• 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
16:15 - 16:50Emerging Markets Stream 1: Russia, CIS, Turkey,Middle East & Africa
• Case examples of successful generic productsregistration in MENA
• 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
16:15 - 16:50Global eSubmissions
• 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
16:15 - 16:50Pharmaceutical Labelling
• 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
16:15 - 16:50Emerging Markets Stream 2: Latin America & 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
16:50 - 16:50Main agenda
SESSIONSREG AFFAIRS IN EMERGING MARKETS, ESUBMISSIONS & PHARMALABELLING DAY 3 - 20/10/2016
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
18:00 - 18:00Main agenda
SESSIONSREG AFFAIRS IN EMERGING MARKETS, ESUBMISSIONS & PHARMALABELLING DAY 3 - 20/10/2016