2018 APEC Good Registration Management (GRM) Regulatory Science Center of Excellence Workshop

2018 APEC Good Registration Management (GRM) Regulatory Science Center of Excellence Workshop
Date: September 26 to September 28, 2018
Location: Taipei Nangang Exhibition Center, Hall 1 & 2 a.k.a TWTC Nangang Exhibition Hall

Day 1. │ Day 2. │ Day 3.

Wednesday, September 26, 2018

Day 1. │ 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 │ 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 2│ 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
15:00~17:00	Group presentation (6 groups)	All speakers of Session A2

Friday, September 28, 2018

Day 3│ 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.
14:30~16:45	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