
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)
10:00 - 10:10 | Welcome and Introduction |
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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 |
9:00 - 10:30 | Review of Pharmaceuticals - Review Process - Project management |
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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 |
All Day | Tour of the Factory for Generic Drugs |
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9:00 - 10:00 | Japanese Pharmacopoeia - History and Legal status - System of establishing JP Master File System |
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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 |
9:00 - 10:00 | Post-marketing Safety Measures for Pharmaceuticals - Collection and Analysis of ADR Information - Information Provision - Consultation Services |
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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