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Day 1

Wednesday, November 20
Day 1 Wednesday, November 20: Time, Sessions, Title, Speaker

Time

Sessions

Title

Speaker

08:00-09:00 Registration (Participants)
09:00-09:15 Opening Ceremony Opening and Welcoming Address Jin Ho Wang (AHC Director)
Congratulatory Remarks 1 Seung Jeong (Minister of MFDS)
Congratulatory Remarks 2 Kyeong Ho Lee (Chairman of KPMA)
09:15-09:35 Keynote speech Driving Pharmacovigilance Success Moo-Young Yoo (Director General of Pharmaceutical Safety Bureau)
09:35-09:45 Photo Session
09:45-10:00 Coffee break
Session 1: Harmonization Efforts on Pharmacovigilance
Co-Chairs: Byung Joo (BJ) Park (KIDS) / Wimon Suwankesawong (Thai FDA)
10:00-10:20 Harmonization Activities on Pharmacovigilance APEC Efforts on Pharmacovigilance and Overview of Pharmacovigilance Roadmap Jong-Pill Park (MFDS)
10:20-10:50 WHO Activities on Pharmacovigilance Shanthi Pal (WHO)
10:50-11:10 ICH Activities on Pharmacovigilance Gerald Dal Pan (US FDA)
11:10-11:30 Academia's Activities on Pharmacovigilance Ian Wong (ISoP)
11:30-12:00 Q&A and Discussion
12:00-13:30 Lunch
Session 2: Issues and Challenges towards Pharmacovigilance Harmonization
Co-Chairs: Sunhee Lee (MFDS) / Antonio Mastroianni (UMC)
13:30-13:40 Global Leadership for the Safer Use of Medicines Antonio Mastroianni (UMC)
13:40-14:00 Readout of the Survey Results from Pharmacovigilance Questionnaire of APEC RHSC Young-Jin Ahn (MFDS)
14:00-14:50 Issues and Challenges Regulatory's Perspective (3) Siti Abdoellah (Indonesia),
Wimon Suwankesawong (Thailand),
Li Zhang (China)
Industry's Perspective Jean-Christophe Delumeau (Bayer)
Academia's Perspective Nam-Kyong Choi (SNU)
14:50-15:10 Coffee break
Session 3: Current Status and Gaps of Pharmacovigilance System in APEC Economies
Co-Chairs: Gerald Dal Pan (US FDA) / Siti Abdoellah (NADFC)
15:10-16:40 Sharing Experiences of Pharmacovigilances Panel Discussion: What are the Current Status and Gaps of Pharmacovigilance?

- How Each Economy is Involved with WHO Monitoring Program
- How Each Economy Adopts the ICH Guidelines for Pharmacovigilance
- What are the Challeges and Gaps of Pharmacovigilance in Each Economy and What are the Needs to Improve/Solve Them
Chile, China, Indonesia, Korea, Malaysia, Peru, Thailand, UMC, USA
16:40-17:00 Coffee break
Session 4: Plenary Lecture - Risk Communication
Co-Chairs: Jin-Ho Lee (KoPERM) / Jean-Christophe Delumeau (Bayer)
17:00-17:35 Risk Communication Introduction and Current Practices Gerald Dal Pan (US FDA)
17:35-17:45 Q&A and Discussion
17:45-17:55 Conclusion and Wrap-Up of the Workshop Program co-chair
17:55-18:00 Closing Remarks Jin Ho Wang (AHC Director)
18:30-20:00 Reception Hosted by AHC

Day 1

Thursday, November 21
Time, Sessions, Title, Speaker

Time

Sessions

Title

Speaker

09:00-12:00 Regulators Only Session
Co-Chairs: Gerald Dal Pan (US FDA) / Donwoong Choi (MFDS)
12:00-13:00 Lunch
Visit Korea Institute of Drug Safety and Risk Management (KIDS) and a Local Pharmacovigilance Institute (Overseas Participant Only)
13:30-14:30 Korea Institute of Drug Safety and Risk Management, KIDS
15:00-16:30 Seoul National University Hospital Pharmacovigilance Center