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Informa
08:00 - 09:00

Registration

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Showing of Streams
10:40 - 11:10

Morning Coffee

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Showing of Streams
12:40 - 14:00

Lunch

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Showing of Streams
15:30 - 16:00

Afternoon Tea

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Showing of Streams
18:00 - 18:05
End of Conference Day Three

End of Conference Day Three

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08:00 - 09:00 60 mins
Registration
09:00 - 09:30 30 mins
Info
Regulatory Affairs in Emerging Markets
Major regulatory changes China: Staying on top of a turbulent environment
  • Ziqun Han - Director, Zen Medical Science Consultancy, UK
  • Exploring CFDA’s latest regulatory updates, including:
  • Reforms designed to accelerate the regulatory review of new drugs
  • Streamlining drug review: Categorisation for applications
  • Redefining a “new” drug
  • Clinical trial application process
  • Expanding manufacturing options
  • Highlighting what these changes will mean in practice for industry
  • Understanding how the CFDA will practically handle these changes including hiring of new staff
  • Discussing how China has harmonised its regulatory environment since joining ICH and how far still to go
09:00 - 09:30 30 mins
eSubmissions and IDMP Compliance
Case Study – Use of a “Global Dossier Concept” to accomplish “same day” submissions in multiple regions
  • Anna Sahl - Submission Manager, Bayer
09:00 - 09:10 10 mins
MENA WORKSHOP
Chairperson’s Opening Remarks
09:10 - 09:40 30 mins
Info
MENA WORKSHOP
Exploring latest regulatory updates in Oman
  • Dr. Mohammed Hamdan Al Rubaie - Director General of Pharmaceutical Affairs & Drug Control, Ministry of Health, Sultanate of Oman
  • Reviewing the current regulatory framework and any upcoming changes
  • Latest updates and progress for eCTD
  • Practical advice for product registration in Oman and overcoming challenges
09:30 - 10:00 30 mins
Info
Regulatory Affairs in Emerging Markets
Case study: Practically complying with the rapidly evolving regulatory landscape in China
  • Ching Li - Manager, Corporate Regulatory Affairs, Biotest Pharma GmbH, Germany
  • Highlighting where challenges lie with the large degree of regulatory change in China and how to deal with these
  • Navigating the best regulatory pathway for successful drug approval
  • Understanding how China joining ICH has impacted industry
09:30 - 10:00 30 mins
eSubmissions and IDMP Compliance
Member state feedback from Thai FDA
  • Thai FDA Representative - -, Thai FDA
09:40 - 10:10 30 mins
MENA WORKSHOP
Regulatory update and practical advice for successful generics' registration in Saudi Arabia
  • Syndie Messager - Market Access and International Regulatory Affairs Coordinator, Laboratorios Cinfa, Spain
10:00 - 10:30 30 mins
Info
Regulatory Affairs in Emerging Markets
Case study: Marketing authorizations and latest regulatory updates in India
  • Andrey Mladenov - Senior Manager Regulatory Affairs, Tillotts Pharma AG, Switzerland
  • Outlining the latest regulatory environment
  • Understanding and complying with clinical data requirements
  • Exploring the standards for new product submissions and renewals
  • Overcoming regulatory challenges and pitfalls
10:00 - 10:30 30 mins
Info
eSubmissions and IDMP Compliance
Experiences in Submitting Dossiers in Thailand
  • Henry Quinn - Senior Regulatory Operations Associate, Gilead Sciences Ltd
  • Clarifying the latest status, agency updates and expectations for eCTD in Thailand
  • Sharing experiences and lessons learnt from Thailand eCTD pilot projects
  • Discussing what remains to be addressed for the adoption of eCTD in Thailand
  • Reviewing experiences from the pilot project and comparing them with the EU eCTD submissions
10:10 - 10:40 30 mins
Info
MENA WORKSHOP
Practical advice for product registration and regulatory updates from the Gulf Cooperation Council (GCC)
  • Abdul Mateen - Regulatory Affairs Consultant, AstraZeneca, UK
  • Reviewing the current regulatory environment in Saudi Arabia and the UAE
  • Sharing experiences with national registrations in the GCC
  • Overcoming challenges faced in the GCC
10:40 - 11:10 30 mins
Morning Coffee
11:10 - 11:40 30 mins
Info
Regulatory Affairs in Emerging Markets
Exploring practical considerations for market entry and the latest regulatory environment in South Korea
  • Eric Ducamp - Associate Director, Global Regulatory Affairs, Ipsen, France
  • Overview of the latest regulatory framework in South Korea
  • What is required for MAA submissions, renewals and variations?
  • Examining requirements for providing GMP data during the registration process
  • Latest on priority review designation and impact on shortened review timelines
  • Discussing requirements for post-market observational studies in South Korea
11:10 - 11:40 30 mins
Info
eSubmissions and IDMP Compliance
Exploring submissions in Brazil
  • ANVISA Representative - -, ANVISA
  • Status update on submissions in Brazil
  •  Timelines for ECTD strategies
11:10 - 11:40 30 mins
Info
MENA WORKSHOP
Latest regulatory updates and best practice for biosimilars registration in Turkey and MENA
  • Parminder Kaur - Founder and RA/PV Consultant, RegPak BioPharma Consulting, The Netherlands
  • Exploring latest regulatory updates across Turkey and MENA for biosimilar products
  • Discussing labelling requirements for biosimilars
  • Outlining clinical data expectations for biosimilars across Turkey and MENA
  • Comparing regulatory requirements to Europe and the US
11:40 - 12:10 30 mins
Info
Regulatory Affairs in Emerging Markets
Japan: Examining the latest regulatory environment and practical experiences with MAA submissions
  • Martine Zimmermann - Global Head of Regulatory Affairs, Alexion Pharma GmbH, Switzerland
  • Exploring the latest regulatory environment and any recent/upcoming changes in Japan
  • Reviewing the degree to which pharmacopeias are aligned between Japan and the US
  • Outlining what is required for MAA submissions, renewals and variations
  • Outlining requirements for post-market observational studies in Japan
11:40 - 12:10 30 mins
eSubmissions and IDMP Compliance
Sharing experiences of successful submissions in GCC
  • Asif Durrani - Team Leader, Regulatory Affairs, Spimaco, KSA
11:40 - 12:10 30 mins
Info
MENA WORKSHOP
Outlining the regulatory environment and practical advice for product registration in Lebanon
  • Ayad Azzi - Regulatory Affairs Manager – Emerging Markets, Boehringer Ingelheim, Germany
  • Discussing the current regulatory framework and any upcoming changes
  • Best practice for submission, including documentation requirements and timelines
  • Exploring requirements for filing variations in Lebanon
  • Successfully collaborating with agents and distributors for registration
12:10 - 12:40 30 mins
Info
Regulatory Affairs in Emerging Markets
Outlining latest regulatory updates in the ASEAN countries and status of the ACTD format
  • Silvia Nita - Global Regulatory Affairs CMC Manager, Roche, Switzerland
  • Evaluating the status of the ACTD format and updates on harmonisation
  • Discussing latest harmonisation efforts across the ASEAN countries
  • Outlining what is required for MAA submissions, renewals and variations
  • Overcoming key challenges and pitfalls
12:10 - 12:40 30 mins
Info
eSubmissions and IDMP Compliance
Outlining latest regulatory updates in the ASEAN countries and status of the ACTD format
  • Silvia Nita - Global Regulatory Affairs CMC Manager, Roche, Switzerland
  • Evaluating the status of the ACTD format and updates on harmonisation
  • Discussing latest harmonisation efforts across the ASEAN countries
  • Outlining what is required for MAA submissions, renewals and variations
  • Overcoming key challenges and pitfalls
12:10 - 12:40 30 mins
Info
MENA WORKSHOP
Regulatory update and complying with requirements for registration in Iran
  • Abid Hussain - Senior Manager Regulatory Affairs, Emcure pharmaceuticals Ltd., UAE
  • Outlining the current regulatory framework and any upcoming changes
  • Best practice for submission, including documentation requirements and timelines
  • Outlining requirements for filing variations in Iran
  • Working successfully with agents and distributors for registration
12:40 - 14:00 80 mins
Lunch
14:00 - 14:30 30 mins
Regulatory Affairs in Emerging Markets
Understanding orphan drug designation requirements and expectations in Japan
  • Lamine Messaoudi - Co-Founder, RegArise, USA
14:00 - 14:30 30 mins
Info
eSubmissions and IDMP Compliance
Roundtables: Question and Answer around the world
  • Satish Mahajan - Manager, Regulatory Operations - Publishing, GSK Consumer Pvt Ltd, UK
  • Thai FDA Representative - -, Thai FDA

Join our global round tables to have your questions answered by our global submission experts.

14:00 - 14:30 30 mins
Info
MENA WORKSHOP
Practical experiences of labelling in Africa and Middle East – An Overview
  • Ronnie Mundair - Regional Labelling Head- Director, Pfizer, UK
  • An overview of the varying landscape within the region

    • Including experience of fast track approvals
  • The influence of the EU on labelling
  • Industry challenges & proposals for consideration
14:30 - 15:00 30 mins
Info
Regulatory Affairs in Emerging Markets
Outlining Australia’s latest regulatory requirements for product registration
  • Mahir Karababa - Head Regulatory Affairs RoW, Santhera Pharmaceuticals AG Ltd, Switzerland
  • Highlighting the latest regulatory environment and any recent/upcoming changes in Australia
  • Determining what is required for MAA submissions, renewals and variations
  • Overcoming key challenges and pitfalls
14:30 - 15:00 30 mins
Info
eSubmissions and IDMP Compliance
Case study for preparing for the Mandate of National submissions
  • James Hendry - Head of Global Regulatory Affairs Operations, GE, UK
  • GE preparations for National submissions
  • Best practices to undertake the workload
14:30 - 15:00 30 mins
Info
MENA WORKSHOP
Latest regulation on the registration of medicinal product and overcoming the challenge of GMP inspections by the Turkish Health Authority
  • Figen Kabadas Oge - Head of Regulatory Affairs, Delpharm, France
  • Understanding the regulatory guidance available for GMP site audits
  • Addressing the long timelines involved with GMP site audits and how long it takes to get approval afterwards
  • Exploring the documentation which must be prepared for GMP site audits and other specific requirements
  • Reviewing whether and when procedures for GMP inspections will change
15:00 - 15:30 30 mins
Info
Regulatory Affairs in Emerging Markets
Harmonization of Labeling and Packaging in APAC
  • Wei Way Kok - Manager Regulatory Competency Center APAC, Hexal AG/Sandoz, Germany
  • Reviewing key requirements for harmonizing labelling and packaging across ASEAN, Australasia and East Asia
  • Challenges and opportunities
  • Case study and recommendations
15:00 - 15:30 30 mins
eSubmissions and IDMP Compliance
Examining the Latest Progress towards eCTD submissions in South Africa
  • Natasha Slater - Regulatory Operations Associate II, Gilead, UK
15:00 - 15:30 30 mins
Info
MENA WORKSHOP
Understanding the prioritisation of local production in Turkey and implications for industry
  • Figen Kabadas Oge - Head of Regulatory Affairs, Delpharm, France
  • Exploring the increased focus on local production in Turkey and implications for foreign manufacturers
  • Outlining the challenges associated with manufacturing products locally in Turkey, including:
  • Size and scope of the company
  • Manufacturing capacity within Turkey
  • Technology, resources and expertise available in Turkey
  • Outlining key differences in what must be guaranteed in GMP for local compared to foreign manufacturers
  • Reviewing how authorities manage with local compared to foreign manufacturers
15:30 - 16:00 30 mins
Afternoon Tea
16:00 - 17:00 60 mins
Regulatory Affairs in Emerging Markets
OPEN FLOOR Q&A DISCUSSION: APAC
  • Ching Li - Manager, Corporate Regulatory Affairs, Biotest Pharma GmbH, Germany
  • Ziqun Han - Director, Zen Medical Science Consultancy, UK
  • Justyna Kwiatkowska - Specialist, Adamed Group, Poland
  • Alan Chalmers - Director, Pharma International, Switzerland
16:00 - 16:30 30 mins
Info
eSubmissions and IDMP Compliance
Introducing PharmaDoc for validating and editing eCTD leaf files and verifying the quality
  • A Representative from Planet Pharma Solutions, Planet Pharma Solutions, Inc.

Planet Pharma Solutions, Inc. introduces PharmaDoc(TM) series software as shown below and the case studies

  • PharmaDoc LeafChecker: Verifies the quality of eCTD leaf files
  • PharmaDoc eCTDSupporters: Validates & edits eCTD leaf files
  • PharmaDoc Redact: Redacts CSR conforming EMA Policy 0070
16:00 - 16:30 30 mins
Info
MENA WORKSHOP
Exploring regulatory requirements and overcoming challenges across Francophone Africa
  • Marta Abascal - International Market Access & Regulatory Affairs Specialist, Laboratorios Cinfa, Spain
  • Comparing regulatory guidelines and requirements
  • Latest update on harmonisation initiatives
  • Practical advice on product registration
  •  Overcoming other key regulatory challenges
16:30 - 17:00 30 mins
Info
eSubmissions and IDMP Compliance
Defining the right level of RA technical checks of regulatory files
  • Carolline Petersen - Project Manager, Novo Nordisk A/S, Denmark
  • Best practices to solve distribution of archives
  • What tools are industry using to archive submissions?
  • Industry feedback on successful submission Archiving
16:30 - 17:00 30 mins
Info
MENA WORKSHOP
Exploring latest status and updates of ‘fast track’ approvals and priority reviews conducted in Turkey and MENA
  • Edmar Campos - Intercontinental Coordinator, Global Regulatory Affairs, Ipsen, France
  • Understanding which countries have started these processes and timelines involved
  • Sharing experiences so far with fast track and priority reviews
  • Examining the process and practical considerations for these types of registration
  • What are the benefits seen with fast track and priority reviews?
17:00 - 18:00 60 mins
MENA WORKSHOP
OPEN FLOOR Q&A DISCUSSION: Middle East and Africa
  • Dr Salah Chettibi - Regulatory Affairs Manager, Kyowa Kirin Services Ltd, UK
18:00 - 18:05 5 mins
End of Conference Day Three