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2019 APEC Good Registration Management (GRM) Regulatory Science Center of Excellence Workshop Agenda
Application of GRM to the Entire Product Life Cycle
Date：Sep. 17-19, 2019
Location: Chang Yung-Fa Foundation International Convention Center

  │September 17, Day 1 │September 18, Day 2 │September 19, Day 3
September 17, Day 1 Sessions
 
Time Topics Speakers
09:00-09:20 Opening Remarks
- Shou-Mei Wu (吳秀梅署長)
Director General, Taiwan Food and Drug Administration (TFDA), MOHW
- Eriko Fukuda
Director, Office of International Cooperation, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
- Shinji Hatakeyama
Leader, Regulations and Approvals Expert Working Group (RA-EWG), Asia Partnership Conference of Pharmaceutical Associations (APAC), Japan
09:20-09:40 Group Photo-Opening
Keynote Speech
Moderator: Shou-Mei Wu (吳秀梅署長)
Director General, TFDA, MOHW
09:40-10:25 Development and Regulatory Approval of Innovative Medicines
- How the regulatory authority engages industry and external experts to promote product development and accomplish the regulatory approval of innovative products		 Max Ning
Medical Officer, Good Clinical Practice Assessment Branch, Division of Clinical Compliance Evaluation, Office of Scientific Investigations, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (US FDA)
Session 1. Introduction of GRM
Moderator: Hwei-Fang Cheng (陳惠芳副署長)
Deputy Director General, TFDA
10:25-10:55 Basic Concept of GRM
- Application of the concept to entire product life cycle
- Achievements of APEC Roadmap to Promote GRM
- Overview of 2019 training program
- Objective of the training: rolling out the GRM training program in each economy		 Mei-Chen Huang (黃玫甄科長)
Section Chief, Division of Medicinal Product, TFDA
Topics of Special Interests
Moderator: Ming-Hsun Liu (劉明勳組長)
Director, Division of Medicinal Product, TFDA
10:55-11:25 How Health Canada Implements Good Review Practices and Measures the Outcomes Using Performance Indicators (tentative title) Dan McManus
Senior Clinical Evaluator, Centre for Evaluation of Radiopharmaceuticals and Biotherapeutics, Division of Hematology and Oncology, Biologics and Genetic Therapies Directorate, Health Canada
11:25-11:40 Q&A Moderator：Ming-Hsun Liu (劉明勳組長)
11:40-12:30 Lunch
Session 2. Planning of Application
Co-Chair: Rosa Fu (傅玉萱)
GRM Coordinator, International Research-Based Pharmaceutical Manufacturers Association (IRPMA)
Associate Director, Regulatory Affairs, Eli Lilly and Company, Taiwan
12:30-12:45 Ice Breaker Rosa Fu (傅玉萱)
Representative, IRPMA, Taiwan
12:45-13:35 Introductory Lectures
- Planning of new drug applications
- Planning of generic drug applications		 Finny Liu (劉瑞芬)
PDR APAC Regional Regulatory Policy Lead, Roche, Singapore
Jocelyn Lee (李涵育)
Regulatory Manager, Project & Regulatory Affairs Division, TTY Biopharm Co., Ltd, Taiwan
13:35-14:45 Case Studies: New Drugs
Case Studies: Generic Drugs		 Moderators: Finny Liu (劉瑞芬) 
and Jocelyn Lee (李涵育)
14:45-15:00 Refreshment Break
Session 3. Preparation of Application Dossier/ Practice: How to Prepare Application Dossier
Chair: Shinji Hatakeyama
Leader, RA-EWG, APAC, Japan
15:00-15:05 Introduction
- Learning Objectives		 Shinji Hatakeyama
Leader, RA-EWG, APAC, Japan
15:05-15:20 Ice Break Hiroko Kawaguchi
Associate Director, Regulatory Strategy & Liaison 1, Regulatory Affairs Area, Japan Development, MSD K.K.
15:20-16:10 Lectures
- Standard Process of Application Dossier Preparation
- Support Tools (Template, Glossary, Checklist & Timeline table)		 Jenny Chang (張淑慧)
Regulatory Affairs Director, HK and Taiwan RA Lead, Merck Sharp & Dohme (I.A.) LLC, Taiwan Branch
Hiroko Kawaguchi
Associate Director, Regulatory Strategy & Liaison 1, Regulatory Affairs Area, Japan Development, MSD K.K.
16:00-17:30 Practice: How to Prepare Application Dossier Moderators: Shinji Hatakeyama
17:30-17:45 Group Photo-Welcome Reception
17:45-21:00 Welcome Reception (Room：1010)

 

September 18, Day 2 Sessions
 
Time Topics Speakers
Session 4. Managing and Conducting the Review
Co-Chair: Eriko Fukuda
Director, Office of International Cooperation, PMDA, Japan
Co-Chair: Yi-Chu Lin  (林意筑科長)
Section Chief, Division of Medicinal Product, TFDA
09:00-10:00 How regulatory authorities manage and conduct the review for typical NDA/BLA and ANDA
- Introduction of GRevP guidelines on managing and conducting the review
- Current practices and outcomes in PMDA		 Wen-Yi Hung (洪文怡高級審查員)
Senior Reviewer, Division of Medicinal Products, TFDA
Aya Myoenzono
Planning and Coordination Officer, Office of International Cooperation, PMDA
10:00-10:20 Refreshment Break
10:20-11:20 Group Discussion
- Participants are divided into 6 groups. Each group will discuss a designated topic covered in managing the review or conducting the review.

Moderators：
Wen-Yi Hung (洪文怡高級審查員)
and Aya Myoenzono
11:20-12:00 Group presentation: Current practices, challenges and potential solutions in different APEC member economies Participating trainees
12:00-13:00 Lunch
Session 5. Critical Thinking and Regulatory Decision-Making
Co-Chair: Jo-Feng Chi (祁若鳳研究員)
Researcher, Division of Medicinal Product, TFDA
Co-Chair: Chyong-Huey Lai (賴瓊慧副院長)
Vice Supertendent, Chang Gung Memorial Hospital (TFDA Advisory Committee member)
13:00-13:20

Principles and Processes of Critical Thinking and Regulatory Decision-Making with Case Studies
- Points to be considered in review process

 Eriko Fukuda
Director, Office of International Cooperation, PMDA, Japan
13:20-14:10 - Experience sharing and case studies from Health Canada Dan McManus
Senior Clinical Evaluator, Centre for Evaluation of Radiopharmaceuticals and Biotherapeutics, Division of Hematology and Oncology, Biologics and Genetic Therapies Directorate, Health Canada
14:10-14:30 Refreshment Break
14:30-15:20 - Experience sharing and case studies from US Max Ning
Medical Officer, Good Clinical Practice Assessment Branch, Division of Clinical Compliance Evaluation, Office of Scientific Investigations, CDER, US FDA
15:20-16:10 - Experience sharing and case studies from EU Nikolai Constantin Brun
Director of Division, Chief Medical Officer, Chair Joint HMA EMA task Force on Big data, Danish Medicines Agency, Medical Evaluation and Biostatistics
16:10-17:00 How Industry Provides Real World Evidence with Clarification of Benefit-Risk Profile to Support Regulatory Review and Decision-Making Yumiko ASANO
Department Manager, Regulatory Affairs Project & Lifecycle Management Unit Chugai Pharmaceutical Co., Ltd.
Hideyuki Nagashima
Group manager, PHC Intelligence Group, Science and Technology Intelligence Dept.
Project & Lifecycle Management Unit Chugai Pharmaceutical Co., Ltd.

 

September 19, Day 3 Sessions
 
Time Topics Speakers
Keynote Speech
Moderator: Ming-Mei Wu (吳明美副組長)
Deputy Director, Division of Medicinal Product, TFDA
09:00-10:00 How EMA Facilitates Development and Regulatory Approval of Innovative Medicines
Application of the GRM concept using real world data to the entire product life cycle.		 Nikolai Constantin Brun
Director of Division, Chief Medical Officer, Chair Joint HMA EMA task Force on Big data, Danish Medicines Agency, Medical Evaluation and Biostatistics
10:00-10:20 Refreshment Break
Session 6. Application of the GRM Concept to the Entire Product Life Cycle
Chair: Chyn-Liang Huang (黃琴喨簡任技正)
Senior Technical Specialist, Division of Medicinal Product, TFDA
10:20-11:10 Application of the GRM Concept to Postmarketing Surveillance - Safety Issues
- Regulator’s perspectives on pharmacovigilance risk assessment and regulatory actions
- Industry perspectives on post-market identification of new risks and assessment for the needs of regulatory actions		 Kuo-Teng Hung (洪國登科長)
Section Chief, Division of Medicinal Product, TFDA
Masato Ohgaki
Manager, Safety and Risk Management Department, DaiichiSankyo Ltd.
11:10-12:00 Sharing of Surveillance Strategies from 9 APEC Member Economies：

1

Mr. Nahum Briant Vergara Salazar
Generic Drugs Reviewer, Drug Review Unit, Instituto de Salud Pública, Chile

2

Ms. Yee Man Mandy Ho
Pharmacist, Drug Office, Department of Health, The Government of Hong Kong SAR, China

3

Ms. Yosita Anggraeni Harjono
Head of Section of Generic Drug Registration, Drug Registration, National Agency of Drug and Food Control (NADFC), Indonesia

4

Ms. Khirul Falisa Binti Mustafa
Senior Principal Assistant Director, Centre for Product Registration (Generic Medicine Section), National Pharmaceutical Regulatory Agency, Malaysia

5

Ms. Mary Keurih
Product Registration Technical Advisor/Section or unit Head, National Department of Health,
Papua New Guinea

6

Ms. Yolanda Yrene Cortez Chaupin de Rojas
Pharmacist, General Directorate of Medicines, Supplies and Drugs (DIGEMID), Ministry of Health, Peru

7

Ms. Regina Rosario S. Obligacion
Senior Evaluator, Food-Drug Regulation Officer III, Center for Drug Regulation and Research, Food and Drug Administration, Philippines

8

Ms. Pattain Yooket
Pharmacist, professional level, Bureau of Drug Control, Thai Food and Drug Administration, Thailand

9

Ms. Nguyen Thi Kieu Anh
Deputy Director, National Institute of Pharmaceutical Technology, Hanoi University of Pharmacy, Vietnam                 
Representatives from 9 member economies
12:00-13:00 Lunch
Session 7. Communications
Co-Chair: Min Chen (李敏珠顧問)
Consultant, TFDA, and Former Director of Division of Pharmacovigilance, Office of Surveillance and Epidemiology, CDER, US FDA
Co-Chair: Maya Kumano
Manager, Regulatory Affairs Biogen Japan Ltd.
13:00-13:20 Overview of Communication mechanisms – Regulators’ Aspects Min Chen (李敏珠顧問)
Consultant, TFDA, and Former Director of Division of Pharmacovigilance, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US FDA
13:20-13:40 Overview of Communication mechanisms – Industry Aspects Maya Kumano
Manager, Regulatory Affairs Biogen Japan Ltd.
13:40-14:40 Group discussion among reviewers and applicants
Sharing of communication mechanisms available in each economy:
1. Communications before submission of an application
2. Communications for issues identified during the application review
3. Communications for post-approval changes (e.g. labeling changes)		 Moderators: Min Chen (李敏珠顧問)
& Maya Kumano
14:40-15:10 Group Presentation Participating trainees
15:10-15:30 Refreshment Break
Session 8. Competencies and Training for Reviewers and Applicants
Co-Chairs: Chyn-Liang Huang  (黃琴喨簡任技正)
Senior Technical Specialist, Division of Medicinal Product, TFDA
Co-Chairs: Suh-Chin Wu (吳夙欽理事長)
Chairman, Regulatory Affairs Professionals Society (RAPS) Taiwan Chapter
15:30-15:50 Regulatory Competency Framework (video presentation) Paul Brooks
Executive Director, Regulatory Affairs Professionals Society (RAPS)
15:50-16:10 Rolling Out the GRM Training Program in Each Economy: Trainer’s Manual Maya Kumano
Manager, Regulatory Affairs Biogen Japan Ltd.
16:10-16:20 Q&A
16:20-16:40 Certificate Award Ceremony
Closing Remarks		 Shou-Mei Wu (吳秀梅署長)
Director General, TFDA, MOHW
Eriko Fukuda
Director, Office of International Cooperation, PMDA