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Generic Drugs

2015 APEC Harmonization Center Generic Drugs Workshop

November 6, 2015 Ritz-Carlton Hotel, Seoul, Korea

2015 APEC Harmonization Center Generic Drugs Workshop : Time, Topics, Speakers
Time Topics Speakers

Friday, November 6, 2015
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)

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)

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


Craig Simon
(Health Canada)

 

Gustavo Mendes Lima Santos (ANVISA)

 

Peter Bachmann (BfArM)

11:40 - 12:00


12:00 - 12:20

 

12:20 - 12:40

 

 

4) WHO
  - Prequalification Team - DMFs and BE
5) Health Canada
  - Regulatory Consideration for DSs and 

    DMFs
6) EDQM
  - Regulatory Consideration for DSs - Active

    Substance Master Files (ASMFs) and 

    Certificates of Suitability (CEPs)

Antony Fake (WHO)


Gary Condran
(Health Canada)


Susanne Keitel (EDQM)
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)

14:00 - 14:25

14:25 - 14:50

Regulatory Perspective (Generic Drug Review Best Practices)
1) Chinese Taipei
  - Generic Marketing Authorization in

    Taiwan
2) Singapore
  - Singapore HSA's perspective


Jo-Feng Chi (TFDA)

 

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)

15:30 - 15:50

 

 

15:50 - 16:10


16:10 - 16:30

Approval Process and Regulatory Updates on Generic Drugs
1) Australia
  - Regulatory Update on Generic Drugs in

    Australia
2) Mexico
  - Mexico's Regulatory Update and 

    Approval Process on Generic Drugs

3) Malaysia
  - Approval Process and Regulatory 

    Updates on Generic Drugs

 


Mariana Gebara-Coghlan
(DoH, Australia)

 

Francisco Garcia Zetina (COFEPRIS)

 

Mazuwin Zainal Abidin 

(MoH, Malaysia)
16:30 - 17:20

Panel Discussion on the APEC Generic Drugs Harmonization
- Current Updates for Specific Topics:

  e.g. Requirements for Stability Test, GMP 

  Requirements, and Approval Application 

  Form
- Other Areas in Need of Regulatory 

  Harmonization

Antony Fake (WHO)
Mark McDonald (WHO)
Susanne Keitel (EDQM)
Peter Bachmann (BfArM)

Jalene Poh (HSA)

Francisco Garcia Zetina (COFEPRIS)

 
17:20 - 17:40 Closing Remarks and Presentation of Certificates Yeowon Sohn (AHC)