2nd PMDA Training Seminar
December 5 to 12, 2011
Tokyo, Japan
The Second PMDA Training Seminar was successfully completed.
Introduction
The Pharmaceuticals and Medical Devices Agency (PMDA) is pleased to announce its 2nd PMDA Training Seminar for International Regulatory Authorities scheduled for December 5-12, 2011. The PMDA training seminar is established for the exchange of pharmaceuticals and medical devices 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.
Target participants
The 2nd PMDA Training Seminar is designed for GMP inspectors for drugs / biologics.
Outline of 2nd PMDA training seminar
This training seminar contains the following topics:
I. Presentations of general descriptions of PMDA's role in Regulation (Day1).
II-1.Key points of GMP inspections (Day 2 and 3)
II-2.Mock inspection and discussion on the results of inspection (Day 4 and 5)
III. Report of current policy on whether/when they decided/will decide on its accession to PIC/S. (Day 6)
Language
The training will be conducted in English. All participants are expected to actively participate in all of the sessions.
Registration fee/Personal expenses
No registration fee is required for this program.
Attendees are,however, responsible for their own travel, lodging and food expenses.
Date / Time
December 5 to 12, 2011
From 10:00 AM to 5:30 PM
(No sessions are scheduled for December 10 and 11(on the weekends), 2011)
Location
PMDA Office
| Address | Shin-kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013, Japan |
|---|---|
| Telephone | +81-3-3506-9456, Facsimile: +81-3-3506-9572 |
On Day 4, we will visit a Manufacturing site for mock inspection in the suburbs of Tokyo.
Eligible Participants
Participation in the 2nd PMDA Training Seminar is limited to GMP inspectors of international regulatory authorities. Confirmation of registration and additional meeting information will be sent to the approved participants.
Program Agenda
Agenda
Day 1
Monday, December 5, 2011
Basic Course
Overview of PMDA’s role in Regulation
| 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) |
| 14:00 - 15:00 | Relief Services for ADR sufferers - Adverse Drug Reaction Relief System - Relief System for Infections Derived from Biological Products |
| 15:00 - 15:30 | Break |
| 15:30 - 16:30 | GCP/ GLP - Regulations (Ministerial Ordinances, Notifications) - Inspection process |
| 16:30 - 17:30 | GMP - Regulations (Ministerial Ordinance, Notifications) - Inspection process |
Day 2
Tuesday, December 6, 2011
Advanced course
GMP Inspection
| 10:00 - 12:00 | Points to Consider in GMP Inspection for Manufacturers of Active Pharmaceutical Ingredients |
|---|---|
| 12:00 - 13:00 | Lunch on your own |
| 13:00 - 15:00 | Points to Consider in GMP Inspection for Manufacturers of Solid Dosage Forms |
| 15:00 - 15:30 | Break |
| 15:30 - 17:30 | Points to Consider in GMP Inspection for Manufacturers of Asceptic Drugs |
Day 3
Wednesday, December 7, 2011
Advanced course
GMP Inspection
| 10:00 - 12:00 | Points to Consider in GMP Inspection for Manufacturers of Biotechnological/Biological Products |
|---|---|
| 12:00 - 13:00 | Lunch on your own |
| 13:00 - 13:45 | Points to Consider in GMP Inspection for Computerized Systems |
| 13:45 - 14:30 | Risk-based GMP Inspection Method |
| 14:30 - 15:00 | Break |
| 15:00 - 16:00 | Outline of Manufacturing Site for Mock Inspection |
| 16:00 - 17:30 | Group Work: Preparation of Checklist for Mock Inspection |
Day 4
Thursday, December 8, 2011
Advanced course
GMP Inspection
| 10:00 - 17:00 | Mock Inspection (all day) |
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Day 5
Friday, December 9, 2011
Advanced course
GMP Inspection
| 10:00 - 12:00 | Group Work: Preparation of Mock Inspection Reports |
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| 12:00 - 13:00 | Lunch on your own |
| 13:00 - 14:00 | Group Work: Preparation of Mock Inspection Reports (continued) |
| 14:00 - 15:00 | Presentation of Mock Inspection Results and Discussion |
| 15:00 - 15:30 | Break |
| 15:30 - 17:30 | Presentation of Mock Inspection Results and Discussion (continued) |
Day 6
Monday, December 12, 2011
Advanced course
Global Cooperation of Inspectorates
| 10:00 - 10:45 | PIC/S Accession Roadmap in Japan |
|---|---|
| 10:45 - 11:30 | Case Reports from Countries made application/preparing application for PIC/S: Current state on Accession to PIC/S (Korea, Indonesia) |
| 11:30 - 12:00 | Open Discussion on a sequence of lessons for Accession to PIC/S |
| 12:00 - 13:00 | Lunch on your own |
Concluding Session
| 13:00 - 14:00 | Wrap up of the Training Seminar |
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