2017 APEC Good Registration Management (GRM) Regulatory Science Center of Excellence Pilot Workshop

2017 APEC GEM Regulatory Science Center of Excellence Workshop Program
Date: October 31-November 2, 2017
Location: National Taiwan University Hospital (NTUH) International Convention Center

Day 1. │ Day 2. │ Day 3.

October 31, 2017

Day 1. │ Common Sessions (reviewers & applicants) Room 401

Time	Subjects	Speakers
08:30~08:45	Opening remarks Shiow-Ing Wu, Deputy Director General, Taiwan Food and Drug Administration, Ministry of Health and Welfare, Chinese Taipei Junko Sato, Office Director, Office of International Cooperation, Pharmaceuticals and Medical Devices Agency (PMDA), Japan Osamu Inagaki, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association
08:45~09:15	Keynote Speech 1: Basic Concept of GRM Moderator: Shiow-Ing Wu Deputy Director General, Taiwan Food and Drug Administration, Ministry of Health and Welfare, Chinese Taipei
	Basic Concept of GRM	Chao-Yi Wang Director, Division of Medicinal Products, Taiwan Food and Drug Administration, Ministry of Health and Welfare, Chinese Taipei
09:15~10:00	Session 1. An Overview of Good Review and Good Submission Chair: Chao-Yi Wang Director, Division of Medicinal Products, Taiwan Food and Drug Administration, Ministry of Health and Welfare, Chinese Taipei
	Lecture 1: An overview of principles of good review and WHO GRevP guidelines	Yi-Chu Lin Section Chief, Section of New Drugs, Division of Medicinal Products, Taiwan Food and Drug Administration, Ministry of Health and Welfare, Chinese Taipei
	Lecture 2: An overview of principles of good submission and APEC GSubP guidelines	Osamu Inagaki Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association
	Q&A
10:00~10:15	REFRESHMENT BREAK
10:15~10:45	Keynote Speech 2: The Role of Good Review Practices in Building Quality Review Process – Canadian Experience Moderator: Chih-Liu Lin Deputy Executive Director, Center for Drug Evaluation, Taiwan
	The Role of Good Review Practices in Building Quality Review Process – Canadian Experience	Christopher Antonio Regulatory Affairs Supervisor, Office of Regulatory Affairs, Biologics and Genetic Therapies Directorate, Health Canada
10:45~12:30	Session 2. Experience Sharing from Different APEC Member Economies Co-Chair: Chao-Yi Wang Director, Division of Medicinal Products, Taiwan Food and Drug Administration, Ministry of Health and Welfare, Chinese Taipei Co-Chair: Junko Sato Office Director, Office of International Cooperation, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
	Current status and challenges of local training and implementation of GRM in APEC member economies Regulators’ perspectives Representatives of Indonesia, Malaysia, Philippines and Singapore Industry perspectives Representatives of SAPI and PReMA Q&A
12:30~13:30	LUNCH

Day 1. afternoon │
Reviewer-Specific Sessions Room 402AB

Time	Subjects	Speaker
13:30~15:30	Session R1. Managing and Conducting the Review Session Chair: Li-Jiuan Hsu Director, Center of Consultation, Center for Drug Evaluation, Taiwan (CDE)
	Experiences sharing from invited experts Lecture 1: An overview of managing and conducting the review based on the WHO GRevP Guidelines	Hsien-Yi Lin Senior Reviewer, Division of Medicinal Products, Taiwan Food and Drug Administration, Ministry of Health and Welfare, Chinese Taipei
	Lecture 2: Experience sharing on new drug applications	Hsin-Jung Lee Senior Medical Reviewer, Division of New Drugs, Center for Drug Evaluation (CDE)
	Lecture 3: Generic Medicine Applications – A regulator’s experience	Keith McDonald Deputy Director, Licensing Division, Medicines & Healthcare Products Regulatory Agency, London
	Q&A
15:30~15:45	REFRESHMENT BREAK
15:45~17:45	Session R2. Managing and Conducting the Review Session Chair: Yoko Aoi Planning and Coordination Officer, Office of International Cooperation, Pharmaceuticals and Medical Devices Agency (PMDA)
	Experiences sharing from trainees How a regulatory authority define and apply the review strategy Experience sharing about conducting the review from each participant - To cover agency review considerations, strategies, and process (presentations from each participating economy) Session wrap up

Day 1. afternoon │
Applicant-Specific Sessions Room 402CD

Time	Subjects	Speaker
13:30~15:30	Session A1. Planning of Application Session Chair: Sannie Chong Head, APAC Technical Regulatory Policy, Roche
	Introduction	SAPI/IRPMA
	What do we want	Rosa Fu Associate Director, Regulatory Affairs, Eli Lilly and Company, Taiwan
	What do we need	Thean Soo Lo Asia-Pacific Leader, Global Regulatory Policy & Intelligence, Janssen, Johnson & Johnson
	How do we do it	Sannie Chong Head, APAC Technical Regulatory Policy, Roche
	Q&A Case Study	Jenny Chang Regulatory Affairs Director, HK and Taiwan Regulatory Affairs Lead, Merck Sharp & Dohme (I.A.) LLC Betty Chuang Head of RA, Novartis Taiwan Rosa Fu Associate Director, Regulatory Affairs, Eli Lilly and Company, Taiwan Sannie Chong Head, APAC Technical Regulatory Policy, Roche Thean Soo Lo Asia-Pacific Leader, Global Regulatory Policy & Intelligence, Janssen, Johnson & Johnson
15:30~15:45	REFRESHMENT BREAK
15:45~17:45	Session A2. Good Submissions for Generic Drug Applications Session Chair: P. Jane Lee Deputy Convener, Pharmaceutical Research and Industry Development Committee, Ching-Kang Foundation, Taipei, Taiwan
	Lecture 1: Good Submission Practice in Malaysia & ASEAN	Gan Ching Ching Senior Manager, Regulatory & Product Development, Kotra Pharma (M) Sdn.Bhd.
	Lecture 2: Good Submissions for Generic Drug Applications	Jocelyn Lee Regulatory Manager, Project & Regulatory Affairs Division, TTY Biopharm Co., Ltd.
	Q&A	Gan Ching Ching Senior Manager, Regulatory & Product Development, Kotra Pharma (M) Sdn.Bhd. Jocelyn Lee Regulatory Manager, Project & Regulatory Affairs Division, TTY Biopharm Co., Ltd. I-Chen Sun Director, Division of Pharmaceutical Science, Center for Drug Evaluation, Taiwan (CDE)
	Experiences sharing from trainees How a regulatory authority define and apply the review strategy Experience sharing about conducting the review from each participant - To cover agency review considerations, strategies, and process (presentations from each participating economy) Session wrap up

November 1, 2017

Day 2 │Reviewer-Specific Sessions Room 402AB

Time	Subjects	Speakers
08:30-10:10	Session R3. Review Personnel – Critical Thinking Session Chair: Ming-Hsiao Chan Director, Division of New Drugs, Center for Drug Evaluation, Taiwan (CDE)
	Part I : Fundamentals and case studies on review of new drug applications Considerations of nonclinical and clinical data presented in new drug applications and evidence-based decision-making	Shih-Ying Yang Pharmacokinetic team leader, Center of Drug Evaluation, Taiwan (CDE) Chi-Hsun Chen Senior Team Leader, Division of Clinical Science, Center for Drug Evaluation, Taiwan (CDE)
10:00~10:40	REFRESHMENT BREAK
10:40~12:00	Part II : Generic Medicine Applications – A regulator’s experience Considerations of data presented in generic drug applications and evidence-based decision-making	Keith McDonald Deputy Director, Licensing Division, Medicines & Healthcare Products Regulatory Agency, London, UK
12:00~13:30	LUNCH
13:30~15:30	Session R4. Communication - Fundamentals and Case Studies for Regulatory Authorities Session Chair: Min Chen Consultant, TFDA and Former Director of Division of Pharmacovigilance, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US FDA
	Discussion among reviewers based on WHO GRevP Guidelines section 5 Fundamentals and US FDA practices	Min Chen Consultant, TFDA and Former Director of Division of Pharmacovigilance, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US FDA
	Communication Practices – Canadian Experience	Christopher Antonio Regulatory Affairs Supervisor, Office of Regulatory Affairs, Biologics and Genetic Therapies Directorate, Health Canada
	Communication practices in Philippines FDA	Benjamin G. Co Director IV, Center for Drug Regulation and Research, Food and Drug Administration, Department of Health, Philippines
15:30~15:45	REFRESHMENT BREAK
15:45~16:45	Wrap up Moderator: Session Chairs of Reviewer-Specific Sessions Summary of outcomes of the reviewer sessions Comments from participants Organize the points to be discussed with applicants

Day 2 │Applicant-Specific Sessions Room 402CD

Time	Subjects	Speakers
08:30-09:30	Session A3. Preparation of Application Dossier/ Practice: How to Prepare Application Dossier Session Chair: Shinji Hatakeyama Director, Japan/Asia Regulatory & Asia Clinical Operations Department, GRA CFU, Medicine Development Center, Eisai Co., Ltd., Japan
	Introduction - Learning objectives	Shinji Hatakeyama Director, Japan/Asia Regulatory & Asia Clinical Operations Department, GRA CFU, Medicine Development Center, Eisai Co., Ltd., Japan
	Ice Breaker - Country specific requirements	Jenny Chang Regulatory Affairs Director, HK and Taiwan Regulatory Affairs Lead, Merck Sharp & Dohme (I.A.) LLC
	Dossier Preparation - Lecture: Standard process of application dossier preparation - Lecture: Support tools (Template, Glossary, Checklist & Timeline table)	Osamu Takarada Regulatory Affairs, Drug Development Division, Sumitomo Dainippon Pharma
09:30~10:00	REFRESHMENT BREAK
10:00~12:00	(Continue) Session A3. Practice: How to Prepare Application Dossier 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, GRA CFU, Medicine Development Center, Eisai Co., Ltd., Japan
10:00~12:00	Group presentation (5 groups)	All speakers of A3
12:00~13:00	LUNCH
13:00~15:30	Session A4. Effective Communications - Focusing Follow-up Actions During Review Period /Practice: Case Study of How to Handle Inquires Session Chair: Toru Yamada Head, Regulatory Affairs Japan, R&D Japan, Merck Serono Co., Ltd
	Introduction - To share session objective	Toru Yamada Head, Regulatory Affairs Japan, R&D Japan, Merck Serono Co., Ltd
	Ice Braking Game - Recognize the importance of communication
	Introduction for communication - Explain effective communication based on GRP
	Practice 1 Learn stakeholder analysis and key points to be considered for communication with stakeholders - Group Discussion 1 - Lecture 1	Kyoko Ueda Development Regulatory Affairs Department, Ikuyaku. Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation
	Practice 2 Learn the points to consider effective communication with the review authorities during review period - Group discussion - lecture	Mari Toji Specialist, Regulatory Intelligence & Management Department, Chugai Pharmaceutical Co., Ltd., Japan
	Practice 3 Learn the points for effective communication/negotiation with stakeholders. Analyze actions RA should take before submission and/or during review period. - Group discussion - Lecture	Naoko Matsui Manager, Asia Development Department, Daiichi Sankyo Co., Ltd., Japan
15:30~15:45	REFRESHMENT BREAK
15:45~16:45	Wrap up Moderator: Session Chairs of Applicant-Specific Sessions Summary of outcomes of the applicant sessions Comments from participants Organize the points to be discussed with reviewers

November 2, 2017

Day 3│Day 3 Common Sessions Room 402

Time	Subjects	Speakers
08:30-10:30	Session 3. Communications Session Chair: Min Chen Consultant, TFDA and Former Director of Division of Pharmacovigilance, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US FDA Practices and interactive discussions between reviewers and applicants based on what were discussed in reviewer-specific sessions and applicant-specific sessions.
08:30~08:40	Introduction : How to improve communications and apply critical thinking for decision making	Kazuo Ushio Director,Regulatory Affairs Coordination, R&D, Santen Pharmaceutical Co., Ltd.
08:40~08:55	Introduction for Group Discussion on the following 2 topics: 1. Best practices for communication within the applicant’s company 2.Effective communication between the applicant and regulatory authority Trainees are divided into 2 topics groups which are consist of 3 discussion groups (Reviewers and applicants should be equally distributed in each group, e.g. 5 reviewers and 5 applicants in 1 group) Facilitators from reviewers and applicants participate in each discussion group.	Min Chen Consultant, TFDA and Former Director of Division of Pharmacovigilance, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US FDA
08:55~09:35	Group Discussion
09:35~10:15	Presentation from each group (5 mins x 6 groups)
10:15~10:30	Closing	Junko Sato Office Director, Office of International Cooperation, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
10:30~10:45	REFRESHMENT BREAK
10:45~12:00	Session 4. Competencies and Training for Reviewers and Applicants Chair: Silke Vogel Deputy Director, Centre of Regulatory Excellence; Associate Dean, Duke-NUS Medical School
10:45~11:00	Presentation RAPS Regulatory Competency Framework	Silke Vogel Deputy Director, Centre of Regulatory Excellence; Associate Dean, Duke-NUS Medical School
11:00~11:15	Presentation Navigating towards Staff Development – Findings from ADB-CoRE project Using Team-Based Learning (TBL) as a Training Framework	James Leong Head of Education, Centre of Regulatory Excellence, Duke-NUS Medical School Silke Vogel Deputy Director, Centre of Regulatory Excellence; Associate Dean, Duke-NUS Medical School
11:15~12:00	Discussion Planning for GRM workshops A. Audience selection B. Considerations for topics and contents C. Potential barriers in implementing TBL	Silke Vogel Deputy Director, Centre of Regulatory Excellence; Associate Dean, Duke-NUS Medical School
12:00~13:30	LUNCH
13:30~15:15	Session 5. Rolling Out the GRM Training Program in Each Economy Chair: Chair: Silke Vogel Deputy Director, Centre of Regulatory Excellence; Associate Dean, Duke-NUS Medical School
13:30~14:00	Presentation Trainer’s Manual : To provide instructions for the Trainer on how to organize and manage a GRM training workshop in each economy	Kae Nakashima Japan Regulatory Portfolio Lead, Oncology Products, Pfizer Japan Inc.
14:00~14:15	Presentation Facilitating Team-based Learning (TBL)	Silke Vogel Deputy Director, Centre of Regulatory Excellence; Associate Dean, Duke-NUS Medical School
14:15~15:15	Application and Role-Playing Practices for facilitation (case examples will be provided) in a TBL setting (2 volunteers will be required, one from industry and the other from NRA)	Silke Vogel Deputy Director, Centre of Regulatory Excellence; Associate Dean, Duke-NUS Medical School James Leong ead of Education, Centre of Regulatory Excellence, Duke-NUS Medical School
15:15~15:30	REFRESHMENT BREAK
15:30~16:30	Wrap up Summary of the 3-day outcomes Future perspectives Comments from participants	GRM CoE Representative
16:30~16:40	CLOSING REMARKS Room 401 Shiow-Ing Wu, Deputy Director General, Taiwan Food and Drug Administration, Ministry of Health and Welfare, Chinese Taipei Junko Sato, Office Director, Office of International Cooperation, Pharmaceuticals and Medical Devices Agency (PMDA), Japan