Introduction
The Pharmaceuticals and Medical Devices Agency (PMDA) is pleased to announce its 6th training seminar for international regulatory authorities scheduled for October 19-23, 2015. The seminar is established for the exchange of drug regulatory information between the PMDA and its counterpart agencies all over the world. The 6th PMDA Training Seminar is designed for officials who are engaged in post-marketing safety measures. In this program, PMDA experts will present
1) PMDA's role in regulation
2) Japanese pharmaceutical regulations
3) Post-marketing safety measures
4) Relief system for adverse health effects and Infections
The training will be conducted in English. All participants are expected to actively participate in all of the sessions.
Eligible Participants
Participation in the PMDA 6th Training Seminar is limited to officials who are engaged in post-marketing safety measures. Confirmation of registration and additional meeting information will be sent to the approved participants. The seminar is not intended for Japan government employees.
Date and Venue
October 19 (Monday), 2015 - October 23 (Friday), 2015 (four and half days)
Pharmaceuticals and Medical Devices Agency (PMDA):
Shin-kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku,Tokyo 100-0013, Japan
Program Agenda (Draft)
| Day 1 (Monday, Oct. 19, 2015) | |
| Time | Topic |
| 13:00 - 14:00 | Registration Open |
| 14:00 - 14:30 | Welcome and Introduction |
| 14:30 - 15:00 | Training Overview / Schedule Announcement |
| 15:00 - 15:45 | Overview of PMDA |
| 15:45 - 16:15 | Break |
| 16:15 - 17:00 | Revised Pharmaceutical Affairs Act |
| 17:00 - 17:45 | Review of Pharmaceuticals |
| Day 2 (Tuesday, Oct.20, 2015) | |
| 10:00 - 10:45 | Clinical Trials and Consultation |
| 10:45 - 11:30 | GCP |
| 11:30 - 12:15 | GMP |
| 12:15 - 13:15 | Lunch on Your Own |
| 13:15 - 14:00 | Japanese Pharmacopoeia/Master File System |
| 14:00 - 14:45 | Overview of Post-marketing Safety Measures for Pharmaceuticals |
| 14:45 - 15:15 | Break |
| 15:15 - 16:00 | Safety Information (including Adverse Drug Reaction Reports and Risk Communication) |
| 16:00 - 16:45 | Risk Management Plan |
| Day 3 (Wednesday, Oct. 21, 2015) | |
| 10:00 - 10:45 | Pharmacoepidemiology for Safety Measures |
| 10:45 - 11:30 | Evaluation of Adverse Drug Reaction Reports |
| 11:30 - 13:15 | Lunch on Your Own |
| 13:15 - 17:00 | Group Work 1 (Causality assessment of ADR and Revision of Package Inserts (Lyrica)) |
| 17:00 - 18:00 | Wrap up: Group Work 1 |
| Day 4 (Thursday, Oct. 22, 2015) | |
| 10:00 - 10:45 | Early Post-marketing Phase Vigilance and The Yellow Letter / Blue Letter |
| 10:45 - 11:30 | PMDA'S Initiatives for Safety Evaluation (including Utilize Electronic Healthcare Data and MID-NET Project) |
| 11:30 - 13:15 | Lunch on Your Own |
| 13:15 - 17:00 | Group Work 2 (Severe Skin Disorders Caused by Lamotrigine (Lamictal)) |
| 17:00 - 18:00 | Wrap up: Group Work 2 |
| Day 5 (Friday, Oct. 23, 2015) | |
| 10:00 - 12:00 | Relief Services |
| 12:00 - 13:00 | Lunch on Your own |
| 13:00 - 15:00 | Case Study of Relief Services |
| 15:00 - 16:00 | Wrap up of the Training Seminar |
| Note: The program is tentative and will be updated. | |
Registration
Registration, request should include the following information about the proposed attendee:
Application form is in Word / PDF format. Please download here. "Application form" , "Application form"
Please fill in all the necessary items on the application form and send it by e-mail at 6th_training_seminar@pmda.go.jp
Registration will close September 18, 2015. Please be sure to allow enough time to obtain your visa.
Fee
There is no registration fee for this seminar.
However, attendees are responsible for their own travel, lodging and food expenses.
Access
Detailed access map is available here
Please use public transportation. Nearest Tokyo Metro Subway Stations:
- 5 minutes walk from Exit 11 of Toranomon Station (G07) on the Ginza Line
- 8 minutes walk from Exit 3 of Kokkai-gijido-mae Station (M14/C07), on the Marunouchi Line, Chiyoda Line
- 8 minutes walk from Exit A13 of Kasumigaseki Station (M15/H06/C08), on the Marunouchi Line, Chiyoda Line, Hibiya Line
- 10 minutes walk from Exit 8 of Tameike-sanno Station(G06/N06), on the Ginza Line, Nanboku Line
Contact
For more information, please contact:
Division of Planning and Coordination
Office of International Programs
Pharmaceuticals and Medical Devices Agency
E-mail: 6th_training_seminar@pmda.go.jp
Pharmaceuticals and Medical Devices Agency
Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan