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[KIDS] Pharmacovigilance CoE





2016 APEC Pharmacovigilance CoE Pilot Program

September 6 - 8, 2016 Novotel Ambassador Hotel Seoul, Republic of Korea
Alsac & Provence Hall (2F)
(Regulators ONLY)
2016 AHC Pharmacovigilance CoE Pilot Program : Time, Topics, Speakers
Time Topics Speakers
Day 1: Tuesday, September 6th 2016
Adverse Event(AE) Reporting and Collecting
Session I: Lectures
08:40-09:15 Registration
09:15-09:20 Opening Remarks Bon-Ki Koo
(KIDS)
09:20-10:20 ICH E2B Guideline
    - Necessity for ICH E2B
    - Development direction of Necessity for        E2B (R2→R3)
    - Minimum requirements for application        of ICH-E2B
Gerald Dal Pan
(U.S. FDA)
10:20-10:30 Break
10:30-11:30 Pharmacovigilance Methods
    - Active Surveillance
    - New approaches for effective AE        collection
Daisuke Tanaka
(WHO)
11:30-11:40 Break
11:40-12:40 Global AE collection activities and Ways to encourage AE reporting of patients and healthcare professionals Pi-Hui Chao
(Chinese Taipei)

Linda Harmark
(Lareb)
12:40-14:00 Lunch
Session II: Hands-on Exercise
14:00-16:00 Create an ICSR considering a serious AE related to a Medicine and Consider methods for active AE collecting when a signal is found in AE reporting I
(Group discussion)
G1: Gerald Dal Pan
(U.S. FDA)
Daisuke Tanaka
(WHO)

G2: Rebecca Chandler
(WHO- UMC)
Wei Chuen Tan-Koi
(Singapore)

G3: Hong Ah Kim
(KIDS)
Linda Harmark
(Lareb)
16:00-16:20 Break
16:20-17:20 Create an ICSR considering a serious AE related to a Medicine and Consider methods for active AE collecting when a signal is found in AE reporting II
(Conclusion and wrap up)
Hong Ah Kim
(KIDS)
Day 2: Wednesday, September 7th 2016
Adverse Event(AE) Analysis and Evaluation
Session I: Lectures
09:20-10:20 Requirements for causality assessment
    - Requirements and considerations
    - Methods for causality assessment
    - Ways to overcome gap between        assessments
Rebecca Chandler
(UMC)
10:20-10:30 Break
10:30-11:30 Potential risk detection using accumulated AE Reports
    - Methods for signal detection
    - How to distinguish significant signals
    - Additional pharmacovigilance methods        for risk assessment
Yeonju Woo
(KIDS)
11:30-11:40 Break
11:40-12:40 Risk and Benefit Assessment
    - Definition
    - Performing risk assessment (when, why,        who, how?)
    - Quantative and Qualitive assessments
Gerald Dal Pan
(U.S. FDA)
12:40-14:00 Lunch
Session II: Hands-on Exercise
14:00-16:00 Drug related Benefit/Risk Assessment in a mock scenario I
(Group discussion)
G1: Gerald Dal Pan
(U.S. FDA)
Anki Hagstrom
(UMC)

G2: Rebecca Chandler
(UMC)
Linda Harmark
(Lareb)

G3: Eunsun Noh
(KIDS)
Daisuke Tanaka
(WHO)
16:00-16:20 Break
16:20-17:20 Drug related Benefit/Risk assessment in a mock scenario II
(Conclusion and wrap up)
Eunsun Noh
(KIDS)
Day 3: Wednesday, September 8th 2016
Decision Making, Safety Measures and Risk Communication
Session I: Lectures
09:20-10:20 Risk Management System
    - Definition
    - How to recognize risks
    - Roles of risk management main agent
    - Roles of government in order to        promote public health
Gerald Dal Pan
(U.S. FDA)
10:20-10:30 Break
10:30-11:30 Decision making for safety measures
    - When, why, who, how?
    - Requirements considerations
    - Tools and indicators for effective safety        measures
Norleen Mohamed Ali
(Malaysia)

Gerald Dal Pan
(U.S. FDA)
11:30-11:40 Break
11:40-12:40 Effective Risk Communication
    - Risk Impact of communication
    - Challenges in risk communication
Wei Chuen Tan-Koi
(Singapore)
12:40-14:00 Lunch
Session II: Hands-on Exercise
14:00-16:00 Decision making and communication in a scenario where a risk has been identified I
(Small group discussion)
G1: Norleen Mohamed Ali
(Malaysia)
Daisuke Tanaka
(WHO)

G2: Chih Tzer Choong
(Singapore)
Wei Chuen Tan-Koi
(Singapore)

G3: Su-Jin Kim
(KIDS)
Rebecca Chandler
(UMC)
16:00-16:20 Break
16:20-17:20 Decision making and communication in a scenario where a risk has been identified II
(Conclusion and wrap up)
Wei Chuen Tan-Koi
(Singapore)

Su-Jin Kim
(KIDS)
17:20-17:30 Wrap Up and Closing Remarks