Purpose:
Globalization of development, manufacturing, trade, and marketing of drugs has been progressing, and cooperation of regulatory activities amongst pharmaceutical regulatory agencies of each region has become a necessity. Nowadays, Asian countries have become crucial in clinical development and manufacturing of drugs globally, and therefore, collaborative relationships among the Asian regulatory agencies are highly important.
This is the first joint conference being hosted by National Pharmaceutical Control Bureau (NPCB) and Pharmaceutical and Medical Devices Agency (PMDA), with the aim to enhance Malaysia and Japan's mutual understanding of each other's regulatory system, and to promote advancement of pharmaceutical regulations and development. This symposium will offer in-depth presentations and discussions in each area from the pharmaceutical regulatory perspective.
Host:
Pharmaceuticals and Medical Devices Agency (PMDA) , Japan
National Pharmaceutical Control Bureau (NPCB), Malaysia
Support:
Japan Pharmaceutical Manufacturers Association (JPMA)
Malaysian Pharmaceutical Society (MPS)
Date
March 10th and 11th (AM) , 2015
Venue
ALOFT KUALA LUMPUR SENTRAL
No 5, Jalan Stesen Sentral,
50470 Kuala Lumpur,
Malaysia.
Phone: +60 3 2723 1188
Fax: +60 3 2723 1588
www.aloftkualalumpursentral.com
Attendees
150 attendees
Registration
(Symposium concluded)Registration Fee
(Symposium concluded)
Payment Method of Registration Fee
(Symposium concluded)
Accommodation
(Symposium concluded)
Inquiries
The Secretariat:
1st Malaysia - Japan Symposium on Pharmaceutical Regulatory System
(Attn: Ms. Sha Yee Vonne)
c/o Centre for Organisational Development
National Pharmaceutical Control Bureau (NPCB),
Ministry of Health Malaysia,
Lot 36, Jalan Universiti,
46200 Petaling Jaya, Selangor.
Phone : (603) 7801 8489
Fax : (603) 7958 2960
E-mail : shayeevonne@bpfk.gov.my
Translation
Simultaneous translation to be provided for Japanese and English
Programme
As below:
1st Malaysia - Japan Symposium on Pharmaceutical Regulatory System
Day 1 (10 March 2015) | |
8:30-9:00 | Registration of Participants Symposium Narration: Ms. Syuhadah Mohamed Hassan, NPCB |
9:00-10:00 | Updates / Keynote > "An Overview" Mdm. Siti Aida Abdullah, Deputy Director, Centre for Organisational Development, NPCB > "Role and Vision of PMDA -Promoting Global Public Health-" Dr. Taisuke Hojo, Senior Executive Director, PMDA Photo Session |
10:00-10:30 | Morning Break |
10:30-12:30 | Session 1: Regulatory Review & Updates Chair: Mdm. Anis Talib, Deputy Director Centre for Product Registration, NPCB > "Japan regulatory system for pharmaceutical products and Active Pharmaceutical Ingredients" Dr. Hiroaki Yamada, Office Director, Office of New Drug II, PMDA > "Malaysia Regulatory System for Pharmaceutical Products" Mdm. Rosilawati Ahmad, Senior Principal Assistant Director, Centre for Product Registration, NPCB |
Discussion | |
12:30-14:00 | Lunch |
14:00-16:00 | Session 2: Guidelines & References Chair: Mr. Teruyoshi Ehara, Office Director, Office of Int'l Programs, PMDA > "Halal Pharmaceuticals - Regulatory Perspectives" Dr. Tajuddin Akasah, Deuputy DIrector, Centre for Quality Control, NPCB > "Malaysia Herbal Monograph" Mdm. Mazli Muhammad, Senior Principal Assistant Director, Centre for Quality Control, NPCB > "Japanese Pharmacopoeia(JP) - Present and Future" Seiko Miyazaki, Office Director, Office of Standards and Guidelines Development, PMDA |
Discussion | |
16:00-17:30 | Afternoon Break & Networking Session |
End of Day 1 |
Day 2 (11 March 2015) | |
9:00-10:15 | Session 3: NPCB Sessions Chair: Ms. Sameerah binti Shaik Abdul Rahman, Deputy Director, Centre for Post-Registration of Products, NPCB > "Regulatory Control for Herbal/traditional Medicines and Health Supplement Products in Malaysia" Datin Shantini a/p Thevendran, Senior Principal Assistant Director, Centre for Product Registration, NPCB > "Regulatory Control of Generic Medicines in Malaysia" Ms. Khirul Falisa Nustafa, Principal Assistant Director, Centre for Product Registration, NPCB |
Discussion | |
10:15-10:45 | Morning Break |
10:45-12:00 | Session 4: PMDA Sessions Chair: Mr. Daisuke Koga, Deputy Director for Medical Devices, Office of Int'l Programs, PMDA > "Risk Based Approaches in the Japan-GMP Regulation" Dr. Kentaro Hara, Principal Inspector, Office of Manufacturing/Quality and Compliance, PMDA > "Regulatory Framework for Biotherapeutic Products Including Similar Biotherapeutic Products" Dr. Yasuhiro Kishioka, Principal Reviewer, Office of Cellular and Tissue-based Products PMDA |
Discussion | |
12:00-12:30 | Closing Remarks > Mr. Teruyoshi Ehara, Office Director, Office of Int'l Programs, PMDA End of Symposium |
12:30-14:00 | Lunch |