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4th PMDA Training Seminar

Seminar highlights

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4th PMDA Training Seminar  











 

Introduction

The Pharmaceuticals and Medical Devices Agency (PMDA) is pleased to announce its fourth PMDA Training Seminar for International Regulatory Authorities scheduled for February 3-7, 2014. 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 4th PMDA Training Seminar is designed for officials who are engaged in review of generic drugs.
In this program, PMDA experts will present

1) General descriptions of PMDA's role in Regulation

2) General descriptions of Japanese pharmaceutical regulations

3) General descriptions of review of generic drugs, their case studies

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 Training Seminar is limited to officials who are engaged in review of generic drugs. Confirmation of registration and additional meeting information will be sent to the approved participants.

Date / Time

February 3 to 7, 2014, 9:00 a.m. to 5:30 p.m.

Program Agenda (Draft)

Day 1 (Monday, February 3, 2014)

10:00 - 10:10 Welcome and Introduction
10:10 - 12:00 Training overview / Schedule
Overview of PMDA (Organization, Activities)
12:00 - 13:00 Luncheon Seminar (Scheduled)
13:00 - 15:00 Japanese Drug Regulation
  - Pharmaceutical Affairs Act
  - Approval, license and review
OTC, Quasi-drugs
  - Review Process
  - Regulations
15:00 - 15:30 Break
15:30 - 16:30 GCP
  - Regulations (Ministerial Ordinances, Notifications)
  - Inspection process
16:30 - 17:30 GMP
  - Regulations (Ministerial Ordinance, Notifications)
  - Inspection process

 

Day 2 (Tuesday, February 4, 2014)

9:00 - 10:30 Review of Pharmaceuticals
  - Review Process
  - Project management
10:30 - 11:00 Break
11:00 - 12:00 Biosimilars
  - Regulations (Ministerial Ordinance, Notifications, guidelines)
12:00 - 13:00 Luncheon Seminar (Scheduled)
13:00 - 14:30 Bioequivalence
  - Review Process
  - Regulations
14:30 - 15:00 Break
15:00 - 17:00 Group Work 1 (Bioequivalence)
  - Case Study

 

Day 3 (Wednesday, February 5, 2014)

All Day Tour of the Factory for Generic Drugs

 

Day 4(Thursday, February 6, 2014)

9:00 - 10:00 Japanese Pharmacopoeia
  - History and Legal status
  - System of establishing JP
Master File System
10:00 - 10:30 Break
10:30 - 12:00 Quality (CMC)
  - Review Process
  - Regulations
12:00 - 13:00 Luncheon Seminar (Scheduled)
13:00 - 15:00 Group Work 2 (Quality)
  - Case Study
15:00 - 15:30 Break
15:30 - 17:00 Reports from Attendee

 

Day 5 (Friday, February 7, 2014)

9:00 - 10:00 Post-marketing Safety Measures for Pharmaceuticals
  - Collection and Analysis of ADR Information
  - Information Provision
  - Consultation Services
10:00 - 10:30 Break
10:30 - 11:30 Relief Services
  - Relief System for Adverse Health Effects
  - Relief System for Infections Acquired through Biological Products
11:30 - 13:00 Luncheon Seminar(Scheduled)
13:00 - 14:00 Regulatory Science
  - Science Board
14:00 - 14:30 Break
14:30 - 15:30 Wrap up of the Training Seminar

 

Location

Pharmaceuticals and Medical Devices Agency (PMDA):

Shin-kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku,Tokyo 100-0013, Japan

JCN 3010005007409

Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki,
Chiyoda-ku, Tokyo 100-0013 Japan

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