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) |