2015 APEC Harmonization Center Generic Drugs Workshop
November 6, 2015 Ritz-Carlton Hotel, Seoul, KoreaTime | Topics | Speakers |
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Friday, November 6, 2015 |
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09:00 - 09:15 | Opening and Welcoming Remarks | Yeowon Sohn (AHC) Kyeong-Ho Lee (KPMA) |
09:15 - 09:30 | Keynote Speech: Importance of Generic Drugs | Mark McDonald (WHO) |
09:30 - 09:45 | Group Photo and Coffee Break | |
Session I: International Regulatory Harmonization Activities on Generic Drugs
Chair: Antony Fake (WHO) |
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09:45 - 10:00 10:00 - 10:15 |
IGDRP Working Group Activity Updates - Biowaiver Working Group - Drug Master Files (DMFs) Working Group | Craig Simon (Health Canada) Antony Fake (WHO) |
10:15 - 10:30 | Q&A | |
Session II: Global Regulatory Requirements for Bioequivalence (BE), Biowaivers, and Drug Substance (DSs)/Drug Master Files (DMFs)
Chair: Mark Mcdonald (WHO) |
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10:30 - 10:45 10:45 - 11:05 11:05 - 11:25 |
Requirements for BE, Biowaiver, and DSs/DMFs 1) Health Canada - Overview of BE Requirements 2) ANVISA - Regulation in BE and Biowaiver: Trend and Challenges 3) BfArM - EU Requirements on BE and Biowaiver |
Gustavo Mendes Lima Santos (ANVISA)
Peter Bachmann (BfArM) |
11:40 - 12:00
12:20 - 12:40
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4) WHO DMFs Substance Master Files (ASMFs) and Certificates of Suitability (CEPs) |
Antony Fake (WHO)
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12:40 - 13:00 | Q&A and Discussion | Craig Simon (Health Canada) Gustavo Mendes Lima Santos (ANVISA) Peter Bachmann (BfArM) Gary Condran (Health Canada) Antony Fake (WHO) Susanne Keitel (EDQM) |
13:00 - 14:00 | Lunch | |
Session III: Generic Drug Review Efficiencies
Chair: Mariana Gebara-Coghlan (DoH, Australia) |
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14:00 - 14:25 14:25 - 14:50 |
Regulatory Perspective (Generic Drug Review Best Practices) Taiwan |
Jalene Poh (HSA) |
14:50 - 15:15 | Q&A and Discussion | Jo-Feng Chi (TFDA) Jalene Poh (HSA) |
15:15 - 15:30 | Coffee Break | |
Session IV: Regulatory Updates on Generic Drugs in APEC Member Economies
Chair: Susanne Keitel (EDQM) |
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15:30 - 15:50
15:50 - 16:10 |
Approval Process and Regulatory Updates on Generic Drugs Australia Approval Process on Generic Drugs 3) Malaysia Updates on Generic Drugs |
Francisco Garcia Zetina (COFEPRIS)
Mazuwin Zainal Abidin (MoH, Malaysia) |
16:30 - 17:20 | Panel Discussion on the APEC Generic Drugs Harmonization e.g. Requirements for Stability Test, GMP Requirements, and Approval Application Form Harmonization |
Antony Fake (WHO) Jalene Poh (HSA) Francisco Garcia Zetina (COFEPRIS)
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17:20 - 17:40 | Closing Remarks and Presentation of Certificates | Yeowon Sohn (AHC) |