- New Drug Review, GMP Inspection, Pharmacovigilance -
September 1st, 2014
(Updated on December 10th, 2014)
Pharmaceuticals and Medical Devices Agency
Purpose:
Globalization of research and development, manufacturing and marketing of pharmaceutical drugs has progressed, and cooperation in regulatory activities amongst pharmaceutical regulatory agencies has become a necessity. Nowadays, Asian countries have become significant in the area of clinical development and manufacturing of pharmaceuticals, and therefore, PMDA strives to strengthen the collaborative relationship with the Asian regulatory agencies.
This symposium is cohosted by ThaiFDA, the regulatory agency of Thailand, and PMDA, the regulatory agency of Japan, as in the 1st Symposium held in 2013. The aim of this symposium is to continue to strengthen Thailand and Japan's mutual relationship and cooperative framework for pharmaceutical regulation and promote thorough understanding of regulatory systems of the two host countries amongst the pharmaceutical industries.
Host:
Thai Food and Drug Administration (Thai FDA), Pharmaceuticals and Medical Devices Agency (PMDA)
1. Date [ The Symposium was already held ]
October 15th (Wed) - 16th (Thu), 2014
2. Venue
The Four Wings Hotel Bangkok
| Address: | 40 Sukhumvit Road 26, Klongtoey, Bangkok 10110 Thailand |
| Tel: | +66-2-260-2100 |
| URL: | http://www.fourwingshotel.com/ |
3. Number of Participants
| Participants: | 200 |
Note that online registration will be closed when the number of the participants reaches 200.
4. Registration
| Online Registration: | http://fdaolap.fda.moph.go.th/annualmeeting/register.asp |
| Registration Fee: | THB 1,500 (Approximate: ¥4,850) |
| Deadline: | October 10th, 2014 |
Please register online before the bank payment.
| Bank payment: | Account name: TH-JP Symposium Account number: 340-219862-7 Account type: Savings account Bank: Siam Commercial Bank Branch: Ministry of Public Health |
5. Interpretation
Simultaneous interpretation (Thai-Japanese/Japanese-Thai)
6. Agenda
Day 1 (October 15th)
| 9:30-10:30 (60') | Registration | |
| 10:30-11:00 (30') | Opening Remarks | |
| MC: | Dr. Nantana Kaisaeng (Office of International Affairs, ThaiFDA) (1) Dr. Kazuhiro Shigetoh (Executive Director, PMDA) (2) Mr. Akihiko Uchikawa (Minister of Economics, Embassy of Japan in Thailand) (3) Dr. Boonchai Somboonsook (Secretary-General, ThaiFDA) |
|
| 11:00-12:00 (60') | Session 1: New Drug Review and Pharmaceutical Affairs Act | |
| Chair: | 1) Dr. Yuppadee Javroongrit (Senior Expert on Pharmaceuticals Standard, ThaiFDA) 2) Mr. Kaoru Misawa (International Coordination Officer for Pharmaceuticals, PMDA) |
|
| (1) | New Drug Review System of ThaiFDA (60') Dr. Tharnkamol Chanprapaph (Bureau of Drug Control, ThaiFDA) |
|
| 12:00-13:30 (90') | Lunch Time | |
| 13:30-16:00 (150') | Session 1: New Drug Review and Pharmaceutical Affairs Act(continued) | |
| (2) | Recent Update of Medical Product Regulation in Japan (60') Mr. Kaoru Misawa (International Coordination Officer for Pharmaceuticals, PMDA) |
|
| (3) | New Drug Application (NDA) Review of Anticancer Drugs in Japan (60') Dr. Takahiro Nonaka (Review Director, Office of New Drug V, PMDA) |
|
| Discussion |
Day 2 (October 16th)
| 9:30-12:00 (150') | Session 2: GMP Inspection | |
| Chair: | 1) Mr. Vinit Usavakidviree (Senior Advisor in Safety, Effectiveness and Advisory in Safety and Efficacy of Health Products, ThaiFDA) 2) Mr. Daisuke Koga (Deputy Director for Medical Devices, Office of International Programs, PMDA) |
|
| (1) | ThaiFDA and PIC/S Membership (60') Ms. Thitiporn Tanratanawongs (Bureau of Drug Control, ThaiFDA) |
|
| Coffee Break (15') | ||
| (2) | Participation in PICS (60') Mr. Ichiro Tsunoi (Director, Office of Manufacturing/Quality Compliance, PMDA) |
|
| Discussion (15') | ||
| 12:00-13:30 (90') | Lunch Time | |
| 13:30-16:30 (180') | Session 3: Pharmacovigilance | |
| Chair: | 1) Ms. Sukanya Jiarapong (Senior Expert in Safety and Efficacy of Drugs and Drugs Usages, ThaiFDA) 2) Mr. Daisuke Koga (Deputy Director for Medical Devices, Office of International Programs, PMDA) |
|
| (1) | Data Management and Utilization of Pharmacovigilance (90') 1. Ms. Wimon Suwankesawong (Head of Health Product Vigilance Center, ThaiFDA) 2. Ms. Sareeya Wechwithan (Health Product Vigilance Center, ThaiFDA) |
|
| Coffee Break (15') | ||
| (2) | Present and Future of Drug Safety Measures in Japan (45') Ms. Kaori Yamada (Division of Epidemiology, Office of Safety I, PMDA) |
|
| Discussion (30') | ||
| 16:30-17:00 (30') | Closing Remarks | |
| (1) | Dr. Pathom Sawanpanyalert (Deputy Secretary-General, ThaiFDA) |
|
| (2) | Dr. Mayumi Shikano (Associate Center Director for Advanced Review with Electronic Data Promotion and Science Board, PMDA) |
7. Contact
Thailand:
Dr. Nantana Kaisaeng
Office of International Affairs, Thai food and Drug Administration
Tel: +66-2-590-7286
Fax: +66-2-591-8475
E-mail: KAISAENG@fda.moph.go.th
Japan:
Dr. Kosuke Haneda
Office of International Programs,
Pharmaceuticals and Medical Devices Agency
Tel: +81-3-3506-9456
Fax: +81-3-3506-9572
E-mail: haneda-kosuke@pmda.go.jp