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Previous Workshops

Day 1

Wednesday, May 22
Day 1 Wednesday, May 22 :Time, Agenda,

Time

Agenda

08:00-08:30

Registration

08:30 - 09:00

Opening Ceremony
Welcoming comments: Jin-Ho Wang, Director, APEC Harmonization Center
Congratulatory Message: Byung-Won Jang, Vice President, Ministry of Food and Drug Safety
Introductory comments: Mark Paxton, U.S. Food and Drug Administration, APEC Regulatory Harmonization Steering Committee

09:00 - 09:15

Summary of APEC LSIF Activities to Combat Counterfeit/Falsified Medicines
Jeffrey Gren, Director Office of Health and Consumer Goods, U.S. Department of Commerce

09:15 - 09:30

Medical Product Quality and Supply Chain Integrity and Gap Analysis
Mark Paxton, U.S. Food and Drug Administration, APEC Regulatory Harmonization Steering Committee

09:30 - 10:40

Presentation on the Importance of Medical Product Safety Public Awareness
Moderator: Mark Paxton, U.S. Food and Drug Administration, APEC Regulatory Harmonization Steering Committee
Panelist: Shaba Mohammed, Assistant Director, Nigeria National Agency for Food and Drug Administration and Control
Retno Tyas Utami, Deputy Chairman for Therapeutic Product, Narcotics, Psychotropic and Addictive Substance Control, Indonesia National Agency for Drug and Food Control
Libby Baney, Executive Director, Alliance for Safe On-line Pharmacies
Q&A

10:40 - 10:55

Tea and Coffee Break

10:55 - 12:05

Medical Product Public Awareness in APEC Economies - Case Studies and Best Practices
Moderator: Jeffrey Gren, Director Office of Health and Consumer Goods, U.S. Department of Commerce
Panelists: Manzatul Azrul Azrie Bin Sulaiman, Director, Ministry of Health Malaysia
Yuwadee Patanawong, Thailand Food and Drug Administration
Hsueh Yung (Mary) Tai, Senior Specialist, Chinese Taipei Food and Drug Administration
Q&Amp;A

12:05 - 13:05

Lunch

13:05 - 14:10

Patient Organization and Industry Activities Related to Drug Safety Public Awareness
Moderator: Jeannie Salo, Director of International Government Affairs, Eli Lilly
Panelists: Bejon Misra, Director India Office, Partnership for Safe Medicines
Abul Hashem, Vice President for Business Development, Project HOPE
(due to a last minute problem Abul Hashem was not able to attend, but his presentation is included in the workshop downloads)
Simon Collier, Senior Director, Eisai Co., Ltd.
Q&A

14:10 - 14:30

Overview of Draft APEC Public Awareness Tool Kit
Simon Collier, Senior Director, Eisai Co., Ltd.

14:30 - 15:00

Tea and Coffee Break

15:00 - 16:00

Discussion of Proposal for APEC Public Awareness Tool Kit
Moderators for each discussion:
Mark Paxton, Jeannie Salo, Manzatul Azrul Azrie Bin Sulaiman, Simon Collier, Libby Baney, Bejon Misra, Anita Derks, Retno Tyas Utami

16:00 - 17:15

Reporting of Discussion Groups on Draft APEC Public Awareness Tool Kit and General Discussion

17:15 - 17:30

Concluding Comments for First Day of Workshop

18:00 - 19:30

Hospitality Reception

Day 2

Thursday, May 23
Day 2 Thursday, May 23 : Thursday, May 23: Time, Agenda

Time

Agenda

08:30 - 09:15

Public Awareness in the Age of the Internet - The Threat of Illegal Online Drug Sellers
Libby Baney, Executive Director, Alliance for Safe On-line Pharmacies

09:15-10:00

Presentations on the Importance of a Single Point of Contacts(SPOCs) for Medical Products
Moderator: Anita Derks, Head of Compliance Audit, Asia Pacific Region, Roche
Panelists: Aline Plancon, INTERPOL
Samson Chiu, Director of Asia-Pacific Region, Pharmaceutical Security Institute (PSI) Matthias Stacchetti, Head of Penal Division, Swissmedic
Retno Tyas Utami, Deputy Chairman for Therapeutic Product, Narcotics, Psychotropic and Addictive Substance Control, Indonesia National Agency for Drug and Food Control Stephen Hawgood, Regional Compliance Manager, Eli Lilly
Q&A

10:00 - 10:20

Tea and Coffee Break

10:20 - 11:45

Panel Discussion: Presentations on the Importance of a Single Point of Contact(SPOCs) for Medical Products (Continued)
Q&A

11:45 - 12:15

Proposal for APEC Single Point of Contact System Tool Kit - Overview of Proposal
Matthias Stacchetti, Head of Penal Division, Swissmedic

12:15 - 13:15

Lunch

13:15 - 14:30

Discussion of Proposal for APEC Single Point of Contact Tool Kit
Moderators for each discussion:
Matthias Stacchetti, Jeffrey Gren, Stephen Hawgood, Libby Baney

12:30 - 15:30

Reporting of Discussion Groups on Draft APEC Single Point of Contact Tool Kit and General Discussion

15:30 - 15:45

Tea and Coffee Break

15:45 - 16:45

Discussion Future APEC Regulatory Harmonization Steering Committee Roadmap on Product Quality and Supply Chain Integrity Activities

16:45 - 17:00

Closing Comments

17:00

Workshop Concludes