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GMP and CMC Regulations in Asia: Modernizing Initiatives and Current Regulatory Environment in China, India and ASEAN Markets (Session 402)

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Tuesday 8 November 14:15 – 17.15

ISPE CEUs: 0.25

As the Asia Pacific region becomes a rapidly growing market for new and generic drugs, health authorities in these countries, especially China, India and ASEAN (Association of Southeast Asian Nations), have been actively aligning their regulations and guidelines with those in the U.S. and EU. This session will provide an update on a number of new or emerging CMC and GMP regulations/guidelines in China, India, and ASEAN countries. Country-specific or regional regulations and guidelines on Clinical Trial Application (CTA)/Investigational Drug Application (NDA), Marketing Authorization Application (MAA)/New Drug Application (NDA), Post-Approval Changes/ Variations, Common Technical Document – Quality (CTD-Q), Drug Master Files, and Good Manufacturing Practices (GMP) will be included. Experiences and best practices in implementing these regulations and guidelines will be presented, and challenges facing global pharmaceutical companies will be discussed.

Leaders

Speakers

  • Jeff Campie, USA
  • Richard Forsyth, Senior Consultant, Hyde Engineering + Consulting, USA
  • Nigel Hamilton, Global Quality, Strategy and Process Excellence, Sanofi Aventis, United Kingdom
  • Aisling Horan, Validation Scientist, Alkermes Plc, Ireland
  • Edwin Melendez, Principle Consultant, Parexel, USA
  • Mark O'Reilly, Director Engineering, Alkermes Pharma Ireland Ltd, Ireland
  • Kimberly Ray, A. Director Project Mgmt, Oso Biopharmaceuticals Mfg LLC, USA
  • Julian Wilkins, Vice President, PharmaConsult US Inc, USA
  • Paul Wreglesworth, Independent Consultant, United Kingdom

How You Will Benefit

  • Describe new or emerging CMC and GMP regulations and guidelines in China, India and ASEAN
  • Analyze the recent trends in regulatory CMC and GMP in China, India and ASEAN and understand the new challenges facing a multi-national company
  • Learn from Asia Pacific experts who will share their experiences in applying the new regulations and guidelines

Who Should Attend

Technical, Quality, GMP, and Regulatory Affairs Personnel from a Multi-national, brand or generic companies with responsibilities or interests in Asia Pacific region and ISPE AP Affiliates

Communities of Practice (COPs)

This session is of particular interest to existing and future members of the following ISPE Communities of Practice (COPs):

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