August 2, 2010
Shin Kasumigaseki Bldg, 3-3-2, Kasumigaseki Chiyoda-ku,
Tokyo 100-0013, Japan
Pharmaceuticals and Medical Devices Agency (PMDA)
PMDA Training Seminar
November 29 to December 3, 2010
Tokyo, Japan
The First PMDA Training Seminar was successfully completed.
Introduction
The Pharmaceuticals and Medical Devices Agency (PMDA) is pleased to announce its first PMDA Training Seminar for International Regulatory Authorities scheduled for November 29-December 3, 2010. 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 First PMDA Training Seminar is designed for officials who are reviewing drugs / biologics.
In this program, PMDA experts will present
1) General descriptions of PMDA's role in Regulation (Day1 and 2), and
2) Scientific PMDA review process on new drug applications and biologics applications. (Day 3, 4 and 5).
The program will update participants on the standard as well as latest techniques of reviewing such as pharmacogenomics, biostatistics and quality by design.
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
November 29 to December 3, 2010
From 10:00 a.m - 5:30 p.m
Location
Address
Shin-kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku,
Tokyo 100-0013, Japan
Telephone
+81-3-3506-9456 , Facsimile: +81-3-3506-9572
(See Map below for directions)
Eligible Participants
Participation in the PMDA Training Seminar is limited to reviewers to new drug / biologics applications of International regulatory authorities. Confirmation of registration and additional meeting information will be sent to the approved participants.
Program Agenda
(Draft) Agenda
Day 1
Monday, November 29, 2010
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/ GLP - Regulations (Ministerial Ordinances, Notifications) - Inspection process |
| 15:00 - 15:30 | Break |
| 15:00 - 16:30 | GMP - Regulations (Ministerial Ordinance, Notifications) - Inspection process |
| 16:00 - 17:30 | Relief Services for ADR sufferers - Adverse Drug reaction Relief System - Relief System for Infections Derived from Biological Products |
Day 2
Tuesday, November 30, 2010
Basic Course
Overview of Applications and Reviews
| 10:00 - 11:15 | Review of New Drugs - Review Process - Consultation - Project management |
| 11:15 - 12:00 | Review of New Drugs (Biologics) - Review Process - Consultation - Project management |
| 12:00 - 13:00 | Lunch on your own |
Post marketing Safety Measures
| 13:00 - 15:15 | Post-marketing Safety Measures - Collection and Analysis of ADR Information - Information Provision - Risk Management |
| 15:15 - 15:30 | Break |
Advanced course
Review of New Drugs 1
| 15:30 - 17:30 | Quality |
Day 3
Wednesday, December 1, 2010
Advanced course
Review of New Drugs 2 - 4
| 10:00 - 12:00 | Pharmacology |
| 12:00 - 13:00 | Lunch on your own |
| 13:00 - 15:00 | Pharmacokinetics |
| 15:15 - 15:30 | Break |
| 15:30 - 17:30 | Toxicology |
Day 4
Thursday, December 2, 2010
Advanced course
Review of New Drugs 5 - 7
| 10:00 - 12:00 | Clinical Studies |
| 12:00 - 13:00 | Lunch on your own |
| 13:00 - 15:00 | Biostatistics |
| 15:15 - 15:30 | Break |
| 15:30 - 17:30 | Latest Development in Drug evaluation - Pharmacogenomics to drug development - Global clinical trials |
Day 5
Friday, December 3, 2010
Advanced course
Specialized Training 8
| 10:00 - 12:00 | Over the Counter / Generic Drugs - Bioequivalence - Office of Over the Counter / Generic Drugs' new initiatives (consultations) |
| 12:00 - 13:00 | Lunch on your own |
Basic Course
Overview of Applications and Reviews
| 13:00 - 15:00 | Review of Medical Devices - Review process - Consultation |
| 15:00 - 15:30 | Break |
Concluding Session
| 15:30 - 17:30 | Wrap up of the Training Seminar |