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2nd PMDA Training Seminar

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)

 

Day 5
Friday, December 9, 2011

Advanced course
GMP Inspection

10:00 - 12:00 Group Work: Preparation of Mock Inspection Reports
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

JCN 3010005007409

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

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