International Conference on Expedited Regulatory Pathway for Innovative Medicines
Date : 2017-09-21 08:30:00
To 2017-09-21 17:00:00
Location : Chang Yung-Fa Foundation, International Convention Center
Charge : Free
Organizer : IRPMA
Co-organizer : TsRAP

Registration link: https://goo.gl/forms/CMf9FaupO9q3pkFl1

TEL: 02-27675661

Email: irpma@irpma.org.tw

 

2017 International Conference on Expedited Regulatory Pathway for Innovative Medicines

Date: Sep 21. 2017

Venue: Conference Room 1001, Chang Yung-Fa Foundation, International Convention Center

(10F, No.11, Zhongshan S. Rd., Taipei City)

 

Organizer: IRPMA

Co-Organizer: TsRAP

Advisor: TFDA

 

TIME

TOPICS

SPEAKERS

MODERATORS

08:30-09:00

REGISTRATION

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

09:20-09:50

Expedited Review Process and Timeline in Taiwan

Section Chief, Taiwan FDA, Ministry of Health and Welfare

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

  • Submission Validation Mechanism
  • Review Clock Commitment (NDA & Line Extension)

Dr. Ning Li, M.D., Ph.D., Vice President, GRA & Regulatory Head of China & Asia Region, Sanofi

10:20-10:30

BREAK

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

11:50-13:00

  LUNCH

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

14:30-14:40

BREAK

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