Introduction
The Pharmaceuticals and Medical Devices Agency (PMDA) is pleased to announce its third PMDA Training Seminar for International Regulatory Authorities scheduled for January 21-25, 2013. The PMDA training seminar is established for the exchange of drug and medical device regulatory information between the PMDA and its counterpart agencies all over the world. The training is not open to the pharmaceutical industry or non-regulatory authorities. The training is not intended for Japan government employees.
The 3rd PMDA Training Seminar is designed for officials who are engaged in post-marketing safety measures.
In this program, PMDA experts will present
1) General descriptions of PMDA's role in Regulation (Day 1),
2) General descriptions and cases of Post-marketing Safety Measures (Day 2, 3, and 4)
3) General descriptions and cases of Relief system for adverse health effects and Infections Acquired through Biological Products (Day 5).
The training will be conducted in English. All participants are expected to actively participate in all of the sessions.
There is no registration fee for this program. However, attendees are responsible for their own travel, lodging and food expenses.
Date / Time
January 21 to 25, 2013
From 10:00 a.m. to 5:30 p.m.
Location
PMDA Office
Address
Shin-kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013, Japan
Eligible Participants
Participation in the PMDA 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.
Program Agenda
(Draft) Agenda
Day 1
Monday, January 21, 2013
Basic Course
Overview of Process and Structure
| 10:00 - 10:10 | Welcome and Introduction |
| 10:10 - 11:00 | Training overview / Schedule Overview of PMDA (Organization, Activities) |
| 11:00 - 12:00 | Japanese Drug Regulation - Pharmaceutical Affairs Act - Approval, license and review |
| 12:00 - 13:00 | Lunch on your own |
| 13:00 - 14:00 | Japanese Pharmacopoeia - History and Legal status - System of establishing JP - International Harmonization: Efforts in Pharmacopoeia Discussion Group (PDG) and ICH Q4B |
| 14:00 - 15:00 | GCP - Regulations (Ministerial Ordinances, Notifications) - Inspection process |
| 15:00 - 15:30 | Break |
| 15:30 - 16:30 | GMP - Regulations (Ministerial Ordinance, Notifications) - Inspection process |
| 16:30 - 17:30 | Regulatory Science - Adverse Drug reaction Relief System - Relief System for Infections Derived from Biological Products |
Day 2
Tuesday, January 22, 2013
Basic Course
Overview of Applications and Reviews
| 10:00 - 12:00 | Review of New Drugs - Review Process - Consultation - Project management |
| 12:00 - 13:00 | Lunch on your own |
Advanced course
Post-marketing Safety Measures
| 13:00 - 15:00 | Overview of Post-marketing Safety Measures for Pharmaceuticals - Collection and Analysis of ADR Information - Information Provision - Consultation Services - Risk Manager System |
| 15:00 - 15:30 | Break |
| 15:30 - 17:30 | Overview of Post-marketing Safety Measures for Medical Devices - Collection and Analysis of ADR Information - Information Provision - Consultation Services |
Day 3
Wednesday, January 23, 2013
Advanced course
Post-marketing Safety Measures
| 10:00 - 12:00 | Medical Information for Risk Assessment Initiative (MIHARI) - Evaluation of Risk of Health Information for adverse drug reactions - Development of Electronic Health Information Database |
| 12:00 - 13:00 | Lunch on your own |
| 13:00 - 15:00 | Information Services - PMDA Website - PMDA Medi-Navi |
| 15:00 - 15:30 | Break |
| 15:30 - 17:30 | Risk Management - Risk Management Plan |
Day 4
Thursday, January 24, 2013
Advanced course
Post-marketing Safety Measures
| 10:00 - 12:00 | Case Study 1, Reports from PMDA |
| 12:00 - 13:00 | Lunch on your own |
| 13:00 - 15:00 | Case Study 2, Reports from PMDA |
| 15:00 - 15:30 | Break |
| 15:30 - 17:30 | Case Study 3, Reports from Attendee |
Day 5
Friday, January 25, 2013
Advanced course
Relief System
| 10:00 - 12:00 | Overview of Relief Services - Relief System for Adverse Health Effects - Relief System for Infections Acquired through Biological Products |
| 12:00 - 13:00 | Lunch on your own |
| 13:00 - 15:00 | Case Study |
| 15:00 - 15:30 | Break |
Concluding Session
| 15:30 - 17:30 | Wrap up of the Training Seminar |