- Risk management plan, Pharmacovigilance,
GMP Inspection, Pharmacopoeia -
August 28, 2013
Pharmaceuticals and Medical Devices Agency
Purpose:
Globalization of development, manufacturing, trade, and marketing of pharmaceutical 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 significant in clinical development and manufacturing of drugs, and therefore, PMDA strives to strengthen the collaborative relationship with the Asian regulatory agencies.
This symposium is being hosted by Thai FDA, the regulatory agency of Thailand, where regulations are becoming enriched, and advancement of pharmaceutical industry from various countries including Japan has been active. It is co-hosted by PMDA, the Japanese regulatory agency. The aim of this symposium is to enhance Thailand and Japan's mutual understandings, and to construct a basis in our cooperative system for pharmaceutical regulation and development.
Host:
Thai Food and Drug Administration (Thai FDA), Pharmaceuticals and Medical Devices Agency (PMDA)
Date
October 24th (Thursday)-25th (Friday), 2013
Venue
The Ambassador Hotel Bangkok
Address:
171 Soi Sukhumvit 11 (Chaiyot)
Khlong Toei Nua, Watthana, Bangkok 10110, Thailand
Tel:
+66-2-254-0444
URL:
Number of Participants
Participants:
200
Note that online registration will be closed when the number of the participants reaches 200.
Registration
Online Registration:
http:// wwwapp1.fda.moph.go.th/ annualmeeting/ register.asp
Registration Fee:
THB 1,100 (Approximate: ¥3,500 or US $35)
Deadline:
October 14th, 2013
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
Interpretation
Japanese - Thai
Agenda
Day 1 (October 24th)
| 8:30-9:30 (60') | Registration |
|---|---|
| 9:30-10:30 (60') | Opening Remarks |
| MC: | Dr.Nantana KAISAENG (Office of International Affairs, ThaiFDA) (1) Dr. Boonchai Somboonsook (Secretary-General, Thai FDA) (2) Dr. Tatsuya Kondo (Chief Executive, PMDA |
| 10:30-12:30 (120') | Keynote Lecture |
| Chair: | Dr. Nantana KAISAENG (Office of International Affairs, Thai FDA) |
| (1) | Thai FDA Proactive Role and Proposing Cooperation with PMDA Dr. Yuppadee Javroongrit (Acting Senior Expert on Pharmaceuticals Standard, Thai FDA) |
| (2) | PMDA update and future cooperation with Thailand Mr. Masanobu Yamada (Associate Center Director, PMDA) |
| 12:30-14:00 (90') | Lunch Time |
| 14:00-16:30 (150') | Session 1 |
| Chair: | Mr. Somchai Preechathaweekit (Director, Technical and Planning Division, Thai FDA) |
| Risk Management Plan and Pharmacovigilance: How to ensure the safety of medical products from the clinical trial until post marketing |
|
| (1) | Ms. Wimon Suwankesawong (Head of Health Product Vigilance Center, Thai FDA) |
| (2) | Dr. Tharnkamol Chanprapap (Head of New Drug Subdivision, Thai FDA) |
| Coffee Break | |
| (3) | Dr. Shoji Takamatsu (Office Director of the Office of Safety II, PMDA) |
| 16:30-16:45 (15') | Discussion |
| 16:45-17:00 (15') | Closing |
Day 2 (October 25th)
| 10:00-12:00 (120') | Session 2 |
|---|---|
| Chair: | Dr. Nobumasa Nakashima (Office of International Programs, PMDA) Pharmacopeia Dr. Mayumi Shikano (Office Director of the Office of Standards and Guidelines Development, PMDA) Recognized Pharmacopeia in registration system Mr. Vinit USAVAKIDVIREE (Director, Bureau of Drug Control, ThaiFDA) |
| 12:00-12:15 | Discussion |
| 12:15-13:30 (75') | Lunch Time |
| 13:30-15:30 (120') | Session 3 |
| Chair: | Dr. Yuppadee Javroongrit (Acting Senior Expert on Pharmaceuticals Standard, Thai FDA) |
| GMP inspection | |
| (1) | Mr. Paiboon Amatamahuthanab (Post-marketing Control Division, Bureau of Drug Control, Thai FDA) |
| (2) | Dr. Shingou Sakurai (Office Director of the Office of GMP/QMS Inspection, PMDA) |
| 15:30-16:00 (30') | Closing remarks |
| (1) | Mr. Vinit Usavakidviree (Director, Bureau of Drug Control, Thai FDA) |
| (2) | Dr. Nobumasa Nakashima (Office Director of the Office of International Programs, PMDA) |