| 時間 : | 2017-09-21 08:30:00 |
|---|---|
| 至 | 2017-09-21 17:30:00 |
| 地點 : | 張榮發基金會國際會議中心 |
| 費用 : | 免費 |
| 主辦單位 : | 中華民國開發性製藥研究協會 |
| 協辦單位 : | 台灣醫藥品法規學會 |
報名連結: https://goo.gl/forms/CMf9FaupO9q3pkFl1
1. 藥師學分申請中
2. 主辦單位保有調整議程之權利
3. 本次會議免費，報名後不克參加者，還請來電/信告知，以保障他人參加權益。
連絡電話: 02-27675661
Email: irpma@irpma.org.tw
2017 International Conference on Expedited Regulatory Pathway for Innovative Medicines
創新藥品加速審查流程國際研討會
Date: Sep 21. 2017
Venue: Conference Room 1001, Chang Yung-Fa Foundation, International Convention Center
(10F, No.11, Zhongshan S. Rd., Taipei City)
張榮發基金會國際會議中心1101會議廳（台北市中山南路11號11樓）
Organizer: IRPMA (中華民國開發性製藥研究協會)
Co-Organizer: TsRAP (台灣醫藥品法規學會)
Advisor: TFDA (衛生福利部食品藥物管理署)
|
TIME |
TOPICS |
SPEAKERS |
MODERATORS |
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08:30-09:00 |
REGISTRATION |
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09:00-09:05 |
WELCOME SPEECH |
Mr. David Lin, President, IRPMA |
|
|
09:05-09:15 |
OPENING REMARKS |
Prof. Shou-Mei Wu, Director General, Taiwan FDA, Ministry of Health and Welfare |
|
|
09:15-09:20 |
GROUP PHOTO |
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|
09:20-09:50 |
Expedited Review Process and Timeline in Taiwan |
Dr. Lien-Cheng Chang, Ph. D., Section Chief, Taiwan FDA, MoHW |
Ms. Chao-Yi Wang, Director, Division of Medicinal Products, Taiwan FDA, Ministry of Health and Welfare |
|
09:50-10:20 |
Regulations for Accelerating Innovative Medicines Approvals & Outcomes
|
Dr. Ning Li, M.D., Ph.D., Vice President, GRA & Regulatory Head of China & Asia Region, Sanofi |
|
|
10:20-10:30 |
BREAK |
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10:30-11:00 |
Expedited Review Pathway “Breakthrough (BTD)” in US |
Dr. Sundar Ramanan, Director of Regulatory Policy, Amgen JAPAC |
Prof. Jaw-Jou Kang, Ph.D., National Yang-Ming University, Taiwan |
|
11:00-11:50 |
Regulatory Acceleration Pathways and PRIME Scheme in EU |
Dr. Claudia Hey, Senior Director, Head Europe Global Regulatory & Scientific Policy, Merck KGaA |
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11:50-13:00 |
LUNCH |
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13:00-13:30 |
SAKIGAKE Process |
Mr. Yuji Kashitani, Director, Regulatory Development, Regulatory Affairs Department, TDCJ, Takeda Pharmaceutical Company Limited |
Mr. Ming‐Hsiao Chan, M.D./M.P.H, Director, Division of New Drugs, CDE, Taiwan |
|
13:30-14:00 |
Review clock commitment in Japan |
Ms. Yumi Sato, Senior Director, Clinical Research, Drug Development Division, Sumitomo Dainippon Pharma Co., Ltd. |
|
|
14:00-14:30 |
Review Standard in Indication and Posology in Taiwan |
Mr. Wei-Lun Peng, M.D., Reviewer, Division of New Drug, Center for Drug Evaluation, Taiwan |
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|
14:30-14:40 |
BREAK |
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14:40-15:10 |
Accelerating Approval of Therapies in Orphan Diseases: Experience with FDA & EMA Approaches |
Dr. Iwona Jeske DuPont, Vice President, Innovative Health Rare Disease, Regulatory Head, Pfizer |
Prof. Chyong-Huey Lai, M.D., College of Medicine, Chang Gung University, Taiwan; Chairperson of Drug Advisory Committee TFDA |
|
15:10-15:40 |
The Value of Including Effectiveness Data in Vaccine Prescribing Information – Industry Perspectives |
Dr. Marie-Noëlle Marenne, Director, Head Clinical Regulatory Affairs, GlaxoSmithKline Vaccines |
|
|
15:40-16:10 |
Review Standard in Indication and Posology in JP |
Mr. Kiminori Nagao M.S., R.Ph., Vice President, New Drug Regulatory Affairs Department, R&D Division, Shinagawa R&D Center, Daiichi Sankyo Co., LTD. |
|
|
16:10-16:50 |
PANEL DISCUSSION |
|
Prof. Churn-Shiouh Gau, Ph.D., Chief Executive Director, Center for Drug Evaluation, Taiwan |
|
16:50-17:00 |
CLOSING REMARKS |
Ms. Freda Lin, Standing Director & MRA Chair, IRPMA |
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