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Pharmacovigilance

Workshop Training Program (Closed meeting)

2015 AHC Pharmacovigilance Workshop Program

September 14 -15, 2015 Grand Ballroom 1 & 2 (A3) Ritz-Carlton Hotel Seoul, Republic of Korea

 

2015 AHC Pharmacovigilance Workshop ProgramⅠ : Time, Topics, Speakers
Time Topics Speakers

Monday, September 14, 2015

08:00 - 09:00 Registration
Opening Ceremony
09:00 - 09:15 Opening Remarks and Welcoming Remarks Yeowon Sohn
(AHC Director)
Words of Encouragement/
Congratulatory Remarks
Kyeong-Ho Lee (KPMA)
09:15 - 09:35 Keynote Speech Hyun-Cheol Jeong (MFDS)
09:35 - 09:45 Group Photo
09:45 - 10:00 Break
Session I: Pharmacovigilance and Global Public Health
   Chair: Sun Young Jeong (KIDS)
10:00 - 10:30 Role and Importance of Pharmacovigilance in Global Public Health Daisuke Tanaka (WHO)
10:30 - 10:40 Q&A and Discussion
10:40 - 11:10 WHO-UMC Activities on Pharmacovigilance Anki Hagstrom
(WHO-UMC)
11:10 - 11:20 Q&A and Discussion
11:20 - 11:50 ICH Activities on Pharmacovigilance Gerald J. Dal Pan
(U.S. FDA)
11:50 - 12:00 Q&A and Discussion
12:00 - 13:30 Luncheon (Invited Guests Only)
Session II: Efforts and Challenges towards Pharmacovigilance Harmonization in APEC Economies
   Chair: Daisuke Tanaka (WHO)
13:30 - 13:50 Updates on APEC Pharmacovigilance Roadmap Hyun-Cheol Jeong (MFDS)
13:50 - 14:50 Issues and Challenges of Pharmacovigilance Harmonization
1) Regulatory Perspective
2) Pharmaceutical Industry’s Perspective
3) Academia’s Perspective

Lanette Lee A. Querubin
(Philippines FDA)
Si-Nae Lee (BMS)
Jin-Ho Lee (KOPERM)
14:50 - 15:10 Break
Session III: Special Lecture I
   Chair: Anki Hagstrom (UMC)
15:10 - 15:40 Re-development of ICH E2B (R2&R3): Introduction and key issues Gerald J. Dal Pan
(U.S. FDA)
15:40 - 16:00 Q&A and Discussion
16:00 - 16:20 Break
Session IV: Special Lecture II
   Chair: Gerald J. Dal Pan (U.S. FDA)
16:20 - 16:50 ‘Risk-Benefit Assessment' in Pharmacovigilance Shusen Liu (Merck)
16:50 - 17:10 Q&A and Discussion
17:10 - 17:25 Wrap up and Conclusion Gerald J. Dal Pan
(U.S. FDA)
18:00 - 19:30 Banquet (Invited Guests Only)

Tuesday , September 15, 2015
Sharing Current Status of Pharmacovigilance in APEC Economies
and its Direction Towards Harmonization

Session I: Adverse Event (AE) Reporting
   Chair: Wen-Wen Chen (Durg Relief Foundation)
10:00 - 10:50 Current Status and Policy Direction on “Adverse Event Reporting”
1) Mexico
2) Chinese Taipei
Maria de la Luz Lara Mendez (COFEPRIS)
Wen-Wen Chen (Drug Relief Foundation)
10:50 - 11:10 Break
11:10 - 12:00 Discussion on the Harmonization of Adverse Event Reporting (Panel Discussion) Wen-Wen Chen (Drug Relief Foundation)
Bon-Ki Koo (KIDS)
Anki Hagstrom
(WHO-UMC)
Dra Magaly Tito (DIGEMID)
Maria de la Luz Lara Mendez (COFEPRIS)
12:00 - 13:30 Lunch
Session II: Adverse Event (AE) Evaluation
   Chair: Daisuke Tanaka (WHO)
13:30 - 14:10 Current Status and Policy Direction on “Adverse Event Evaluation”
1) Thailand
2) Malaysia
Wimon Suwankesawong (Thai FDA)
Nafiza Mohd Ismail (MoH Malaysia)
14:10 - 15:00 Discussion on the Harmonization of Adverse Event Evaluation (Panel Discussion) Daisuke Tanaka (WHO)
Niwa Shimpei (JPMA)
Wimon Suwankesawong (Thai FDA)
Norleen Mohamed Ali (MoH Malaysia)
15:00 - 15:20 Break
Session III: Decision Making and Risk Communication
   Chair: Gerald J. Dal Pan (U.S. FDA)
15:20 - 16:00 Current Status and Policy Direction on “Decision Making and Risk Communication”
1) Indonesia
2) Singapore
Siti Asfijah Abdoellah (Indonesia NAFDC)
Dorothy Toh (HSA)
16:00 - 16:50 Discussion on the Harmonization of Decision Making and Risk Communication (Panel Discussion) Gerald J. Dal Pan
(U.S. FDA)
Hyun-Cheol Jeong (MFDS)
Siti Asfijah Abdoellah (Indonesia)
Lanette Lee A. Querubin (Philippines FDA)
16:50 - 16:55 Wrap up and Conclusion Gerald J. Dal Pan
(U.S. FDA)
16:55 - 17:00 Closing Remarks Sun-Hee Lee (MFDS)


[Closed Program]

2015 AHC Pharmacovigilance Training Program

September 16 -18, 2015 Kumkang Room 1&2 (A1F) Ritz-Carlton Hotel Seoul, Republic of Korea
2015 AHC Pharmacovigilance Workshop ProgramⅡ : Time, Topics, Speakers
Time Topics Speakers

Wednesday, September 16, 2015
Understanding Pharmacovigilance System and Adverse Event (AE) Reporting

Session I: Overview of Pharmacovigilance
09:10 - 09:20 Introduction Young-Ju Choi (MFDS)
09:20 - 09:50 Introduction to Pharmacovigilance
- Definition
- Objective
- Scope
- History
Anki Hagstrom
(WHO-UMC)
09:50 - 10:20 Pharmacovigilance Methods Anki Hagstrom
(WHO-UMC)
10:20 - 10:30 Break
Session II: Pharmacovigilance System
10:30 - 11:30 Implementing Pharmacovigilance at National Level
- Necessity for Pharmacovigilance System
- Minimum Requirements for National
  Pharmacovigilance System
  (Organization, Staff, Budget etc.)
- Cases and Examples of APEC
  Pharmacovigilance System
  (Establishing Policies, Legislations and
  Understanding Current Management Status)
Sooyoun Chung (KIDS)
11:30 - 11:40 Break
11:40 - 12:40 Understanding Global Guidelines of Pharmacovigilance
- ICH guideline
- CIOMS recommendation
Gerald J. Dal Pan
(U.S. FDA)
12:40 - 14:00 Lunch
Session III: Adverse Event (AE) Collecting and Reporting
14:00 - 15:00 Managing ICSRs and data exchange in a global PV environment
- Sustainable and fit for purpose data
  management system to handle ICSR data
- The importance of adoption to
  international standards and guidelines to
  allow for global collaboration and data
  exchange
- Minimum requirements in reporting
Magnus Wallberg
(WHO-UMC)
15:00 - 15:15 Break
15:15 - 16:15 The benefit of using standard terminologies in ICSR management
- MedDRA and WHO-ART
- WHO Drug Dictionaries and ISO IDMP
Malin Jakobsson
(WHO-UMC)
16:15 - 16:30 Break
16:30 - 17:30 Implementing Adverse Event Reporting System (DB)
- Minimum Requirements for DB
  Implementation
- Introducing KAERS (Korea Adverse Event
  Reporting System)
Yeonju Woo (KIDS)

Thursday, September 17, 2015
Understanding Adverse Event (AE) Evaluation

Session IV: Adverse Event (AE) Analysis and Assessment
09:20 - 11:20 Causality Assessment of ICSR
- Methodologies of Causality Assessment
- Case Study: Understanding ICSR Case
  Assessment based on Practical Examples
  and Exercise
Gerald J. Dal Pan
(U.S. FDA)
11:20 - 11:40 Break
11:40 - 15:00
(※12:40 - 14:00 Lunch)
Signal Detection and Drug Safety Information Generation
- Definition and Procedure of Data Mining
  and Signal Detection
- Case Study: Understanding Data Mining
  and Signal Detection based on Practical
  Examples and Exercise
Sujin Kim (KIDS)
15:00 - 15:20 Break
Monitoring in Special Fields
15:20 - 16:20 Adverse Event Monitoring on SSFFC Anki Hagstrom
(WHO-UMC)
16:20 - 17:20 Monitoring on Antimicrobial resistance Masaki Sanekata (JPMA)

Friday, September 18, 2015
Understanding Risk Management and Risk Communication

Session V: Risk Management and Risk Communication
09:20 - 11:20 Decision making (Regulatory Action)
- Government’s Decision Making according
  to Adverse Event Evaluation Results
- Case Study: Practical Examples and
  Exercise
Gerald J. Dal Pan
(U.S. FDA)
Min Chen (Taiwan FDA)
11:20 - 11:40 Break
11:40 - 15:00
(※12:40 - 14:00 Lunch)
Overview of Risk Management
- Understanding Definition, Objective, and
  Relationship between Pharmacovigilance
  and Risk Management Concept
- Introduction of Risk Minimization Strategy;
 REMS, RMP
- Establishing Policies for Risk Management;
  Case example
Min Chen (Taiwan FDA)
Ho-Jeong Kim (MFDS)
15:00 - 15:20 Break
15:20 - 17:20 Risk Communication
- Communications with Professionals or
  Patients
- Effective Risk Communication Strategy
- Case Study: Practical Examples and
  Exercise
Adena Lim (HSA)
Min Chen (Taiwan FDA)
17:20 - 17:50 Survey and Conclusion Kyeong-Ho Lee (KPMA)