Date: September 26 to September 28, 2018
Location: Taipei Nangang Exhibition Center, Hall 1 & 2 a.k.a TWTC Nangang Exhibition Hall

Wednesday, September 26, 2018

Day 1. x Common Sessions

Time

Subjects

Speakers

08:30~09:00

Registration

09:00~09:20

Opening Remarks

Shih-Chung Chen (invited)
Minister, Ministry of Health and Welfare

Shou-Mei Wu
Director General, TFDA

Eriko Fukuda
Director, Office of International Cooperation, PMDA

Shinji Hatakeyama
Leader, APAC RA-EWG

09:10~09:20

Group Photo

Keynote Speech
Moderator: Chyn-Liang Huang
Senior Technical Specialist, Division of Medicinal Products, TFDA, Ministry of Health and Welfare

09:20~09:50

Expectation of the EU on Good Registration Management for Medicinal Products

Peter Bachmann
Head of International Liaison Office and Conferences, Federal Institute for Drugs and Medical Device, BfArM, Germany

09:50~10:00

Refreshment Break

Session 1. Introduction of GRM
Chair:Chyn-Liang Huang
Senior Technical Specialist, Division of Medicinal Products, TFDA, Ministry of Health and Welfare

10:00~10:10

Basic Concept of GRM
Basics of GRevP and GSubP Overview of Training Program

Hsien-Yi Lin, PhD
Senior Reviewer, Division of Medicinal Products, TFDA

Session 2. Experience Sharing from Different APEC Member Economies
Co-Chair: Chyn-Liang Huang
Senior Technical Specialist, Division of Medicinal Products, TFDA
Co-Chair: Eriko Fukuda
Director for Office of International Cooperation, PMDA

10:10~12:00

Update with focus on GRM status
Representatives from 12 member economies, 8 min report for each representative

Representatives from 12 member economies

12:00~12:10

Summary report from survey

Hsien-Yi Lin
Senior Reviewer, Division of Medicinal Products, TFDA

12:10~12:30

Panel Discussion:
Challenges and issues of the current GRM status and needs

Representatives from each participating economy

12:30~13:30

Lunch

Session 3. Communications
Co-Chair: Min Chen
Consultant, Taiwan Food and Drug Administration (TFDA), Ministry of Health and Welfare, and Former Director of Division of Pharmacovigilance, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US FDA
Co-Chair: Kazuo Ushio
Director, Regulatory Affairs Coordination, R&D Division, Santen Pharmaceutical Co., Ltd., Japan

13:30~13:50

Overview of Communication – Regulators’ Aspects

Min Chen
Consultant, TFDA, and Former Director of Division of Pharmacovigilance, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US FDA

13:50~14:10

Overview of Communication – Industry Aspects

Kazuo Ushio
Director, Regulatory Affairs Coordination, R&D Division, Santen Pharmaceutical Co., Ltd., Japan

14:10~14:30

Group Discussions
(11-12 trainees/group, total of 6 groups, 5 regulators + 6-7 applicants)


1st Round Group Discussion
Communication issues and challenges you have experienced before in your countries from regulator and industry perspectives

Min Chen/ Kazuo Ushio
Facilitators
TFDA: Pang-Te Lin, Wan-Yu Chen
CDE: Yu-Chun Teng, Jun-Fon Wang
IRPMA: Jenny Chang, Tammie Yang

14:30~15:35

Identify Some Common Issues and Challenges from 1st Round Discussion
2nd Round Group Discussion
How to resolve identified common issues and challenges

Min Chen/ Kazuo Ushio
Facilitators
TFDA: Pang-Te Lin, Wan-Yu Chen
CDE: Yu-Chun Teng , Jun-Fon Wang
IRPMA: Jenny Chang, Tammie Yang

15:35~15:50

Refreshment Break

15:50~17:00

Group Presentations
Summary

18:00~19:30

Welcome Reception (Room 521)

 

Thursday, September 27, 2018

Day 2 x Reviewer-Specific Sessions

Time

Subjects

Speaker

08:30~09:00

Registration

Session 1. Managing and Conducting the Review
Chair: Yi-Jing Kuo
Associate Researcher, Division of Medicinal Products, Taiwan Food and Drug Administration (TFDA), Ministry of Health and Welfare

09:00~09:45

Overview and Experience Sharing on New Drug Applications from CDE

Yi-Tzu Chu
Project Manager, Division of Regulatory Affairs and Compliance, CDE, Taiwan

Session R2. Critical thinking and Regulatory Decision Makings
Chair: Shirley Pan
Senior Technical Specialist, Division of Medicinal Products, TFDA, Ministry of Health and Welfare

09:45~10:30

Introductory Lecture
How EU Regulates Generic Medicines and Train Assessors’ Critical Thinking and Regulatory Decision Making

Peter Bachmann
Head of International Liaison Office and Conferences, Federal Institute for Drugs and Medical Device, BfArM, Germany

10:30~10:50

Refreshment Break

Session R2. Critical thinking and Regulatory Decision Makings
Chair: Shih-Ying Yang
Team leader, Division of Pharmaceutical Science, Center for Drug Evaluation (CDE), Taiwan

10:50~12:30

Case Studies in Generic Drugs
(1 case on CMC)
Trainees will break up into 3 groups
(10 trainees+2 facilitators/1 group)

Efua Anno
Team Manager, Licensing Division, MHRA, UK

Facilitators:
TFDA:
Pang-Te Lin, Jhih-Yu Syu, Wan-Yu Chen
CDE: Li-Feng Hsu, Kai-Ling Chang, Shuo-Hsiu Chang

12:30~13:30

Lunch

13:30~15:00

Case Studies in Generic Drugs
(1 case on BE)
Trainees will break up into 3 groups
(10 trainees+2 facilitators/1 group)

Efua Anno
Team Manager, Licensing Division, MHRA, UK

Facilitators:
TFDA:
Pang-Te Lin, Jhih-Yu Syu, Wan-Yu Chen
CDE: Li-Feng Hsu, Kai-Ling Chang, Shuo-Hsiu Chang

15:00~15:20

Refreshment Break

15:20~17:00

Case Studies in Biosimilar (1 case)
- Trainees will break up into 3 groups (10 trainees+2 facilitators/1 group)

Chiao-Ying Hsu
Medical Reviewer, Division of New Drugs, CDE, Taiwan

Facilitators:
TFDA:
Pang-Te Lin, Jhih-Yu Syu, Wan-Yu Chen
CDE: Li-Feng Hsu, Kai-Ling Chang, Shuo-Hsiu Chang

 

Thursday, September 27, 2018

Day 2x Applicant-Specific Sessions

Time

Subjects

Speaker

08:30~09:00

Registration

Session A1. Planning of Application
Co-Chair: Rosa Fu
Associate Director, Regulatory Affairs, Eli Lilly and Company, Taiwan (IRPMA)
Co-Chair: Thean Soo Lo
Director, Global Regulatory Affairs, Janssen, Johnson & Johnson Asia Pacific, Singapore (SAPI)
Co-Chair: Tricia Chean
Senior Regulatory Affairs Manager, Roche Singapore Pte. Ltd. (SAPI)

09:00~09:15

Ice Breakers

Rosa Fu
Associate Director, Regulatory Affairs, Eli Lilly and Company, Taiwan (IRPMA)

Thean Soo Lo
Director, Global Regulatory Affairs, Janssen, J&J Asia Pacific, Singapore (SAPI)
Tricia Chean
Senior Regulatory Affairs Manager, Roche Singapore Pte. Ltd. (SAPI)

09:15~10:15

Introductory Lecture 1

10:15~10:35

Introductory Lecture 2

Jocelyn Lee
Regulatory Manager, Project & Regulatory Affairs Division, TTY Biopharm, Taiwan

10:35~11:00

Refreshment Break

11:00~12:00

Case Study: New Drugs

Rosa Fu
Associate Director, Regulatory Affairs, Eli Lilly and Company, Taiwan (IRPMA)

Thean Soo Lo
Director, Global Regulatory Affairs, Janssen, J&J Asia Pacific, Singapore (SAPI)
Tricia Chean
Senior Regulatory Affairs Manager, Roche Singapore Pte. Ltd. (SAPI)
Facilitators
IRPMA: Betty Chuang, Carol Hsu, Kelly Tsai, Linda Wu
CPMDA: Julia Lin, Julie Tseng

12:00~12:30

Case Study: Generic Drugs

Jocelyn Lee
Regulatory Manager, Project & Regulatory Affairs Division, TTY Biopharm, Taiwan
Facilitators
IRPMA: Betty Chuang, Carol Hsu, Kelly Tsai, Linda Wu
CPMDA: Julia Lin, Julie Tseng

12:30~13:30

Lunch

Session A2. Preparation of Application Dossier/ Practice: How to Prepare Application Dossier
Chair: Shinji Hatakeyama
Director, Japan/Asia Regulatory & Asia Clinical Operations Department, Medicine Development Center, Eisai Co., Ltd., Japan

13:30~14:45

Introduction
- Learning objectives

Shinji Hatakeyama
Director, Japan/Asia Regulatory & Asia Clinical Operations Department, Medicine Development Center, Eisai Co., Ltd., Japan

Ice Breaker
Country Specific Requirements

Hiroko Kawaguchi
Associate Director, Regulatory Strategy & Liaison 1, Regulatory Affairs Area, Japan Development

Dossier Preparation
Lecture 1: Standard Process of Application Dossier Preparation

Jenny Chang
Regulatory Affairs Director, HK and Taiwan RA Lead, Merck Sharp & Dohme (I.A.) LLC, Taiwan Branch

Dossier Preparation
Lecture 2: Support Tools (Template, Glossary, Checklist & Timeline table)

Osamu Takarada, PhD
Development RA Group, Development Regulatory Affairs, Drug Development Division, Sumitomo Dainippon Pharma Co., Ltd., Japan

14:45~15:00

Refreshment Break

15:00~17:00

Session A2. Practice: How to Prepare Application Dossier (Continue)
Dossier preparation
- Practice
1. Orientation
2. Practice-1
3. Practice-2
Group discussion for presentation

Shinji Hatakeyama
Director, Japan/Asia Regulatory & Asia Clinical Operations Department, Medicine Development Center, Eisai Co., Ltd., Japan

Facilitators
IRPMA: Betty Chuang, Carol Hsu, Jenny Chang
JPMA: Hiroko Kawaguchi, Osamu Takarada, Kae Nakashima

Group presentation (6 groups)

All speakers of Session A2


Friday, September 28, 2018

Day 3x Common Sessions

Time

Subjects

Speakers

08:30-09:00

Registration

Session 4. Comprehensive Exercises in GRM
Chair: Eriko Fukuda
Director, Office of International Cooperation, PMDA, Japan

09:00~09:30

Lecture 1
Preparation and Submission of Labeling

Torkil Fredborg
Senior Director, Global Regulatory Affairs – International, Eli Lilly and Company, UK

09:30~10:00

Lecture 2
Review of Labeling

Yu-Ting Chu
Clinical Reviewer, Division of New Drugs, CDE, Taiwan

10:00~10:40

Case Studies and Practices in Submission and Review of Labeling
(1 case on warning and precaution)

Yu-Ting Chiu
Clinical Reviewer, Division of New Drugs, CDE, Taiwan
Facilitator:
TFDA: Pang-Te Lin
CDE: Yu-Ting Chiu, Jun-Fon Wang
IRPMA: Betty Chuang, Carol Hsu, Jenny Chang, Linda Wu, Rosa Fu, Tammie Yang

10:40~11:00

Refreshment Break

11:00~12:00

Group Presentations
Summary

12:00~13:00

Lunch

Session 5. Competencies and Training for Reviewers and Applicants
Chair: Suh Chin Wu
Chairman, Regulatory Affairs Professionals Society (RAPS) Taiwan Chapter

13:00~13:05

Video

Paul Brooks
Executive Director, RAPS

13:05~13:20

Regulatory Competency Framework

Bing Bing Lin
Consultant, RAPS Taiwan Chapter

13:20~14:15

Competency Gaps
Incorporating a Formal Training Framework for Regulatory Professionals

James Leong
Assistant Professor, Head of Pharmaceutical Regulatory Science Programme, Centre of Regulatory Excellence (CoRE), Duke-NUS Medical School, Singapore
Uttara Soumyanarayanan
Associate, Centre of Regulatory Excellence (CoRE), Duke-NUS Medical School, Singapore
Lavanya Balan
Associate, Centre of Regulatory Excellence (CoRE), Duke-NUS Medical School, Singapore

14:15~14:30

Refreshment Break

Session 6. Rolling Out the GRM Training Program in Each Economy
Chair:James Leong
Assistant Professor, Head of Pharmaceutical Regulatory Science Programme, Centre of Regulatory Excellence (CoRE), Duke-NUS Medical School, Singapore

14:30~16:45

Trainer’s Manual
To provide instructions for the Trainer on how to organize and manage a GRM training workshop in each economy

Kae Nakashima
Manager, Japan Regulatory Lead, Oncology, Regulatory Strategy & Policy, Regulatory Affairs, Pfizer Japan Inc.

Facilitating Team-based Learning
1. Concepts of team-based learning
- Pillars of team-based learning
- Role of facilitators
2. Role-play – What happens in a facilitated discussion using case examples (participants will be divided into smaller teams)

James Leong
Assistant Professor, Head of Pharmaceutical Regulatory Science Programme, Centre of Regulatory Excellence (CoRE), Duke-NUS Medical School, Singapore
Uttara Soumyanarayanan
Associate, Centre of Regulatory Excellence (CoRE), Duke-NUS Medical School, Singapore
Lavanya Balan
Associate, Centre of Regulatory Excellence (CoRE), Duke-NUS Medical School, Singapore

16:45~17:00

Certificate Award Ceremony
Closing Remarks

Shou-Mei Wu, PhD
Director General, Taiwan Food and Drug Administration, Ministry of Health and Welfare.

Eriko Fukuda
Director, Office of International Cooperation, PMDA, Japan