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PMDA-ATC GMP Inspection Seminar 2019

cooperationg with  PIC/S

Introduction

The Pharmaceuticals and Medical Devices Agency (PMDA) is pleased to announce the "PMDA-ATC GMP Inspection Seminar 2019".

This seminar is organized by PMDA Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs (PMDA-ATC) for GMP inspectors from regulatory authorities. The 2019 PIC/S seminar on “Quality Assurance of Sterile Medicinal Products” hosted by MHLW/PMDA is a sub-set of this seminar.  The seminar will be a good opportunity to share the knowledge with inspectors from the world.

The PMDA-ATC GMP Inspection Seminar 2019 is a four-day seminar which starts with half day PMDA-ATC original session and then joins to 2.5-day PIC/S seminar, and ends with half-day PMDA-ATC original session for wrap up.  This series of sessions will provide further understanding of the PIC/S GMP Guide Annex 1 based on issues discussed during its ongoing revision and through a case study of sterility assurance. The seminar will also allow participants to acquire skills on how to make risk-based decisions during GMP inspection.  In PIC/S seminar, videos recorded at manufacturing sites as educational materials will be used, which are expected to stimulate active discussions.

Target participants will be GMP inspectors at beginner or intermediate level. This seminar will enable inspectors to conduct risk-based GMP inspection.

Key seminar objective

  1. To acquire and level up skills on how to make risk-based decisions during GMP inspection
  2. To get further understanding of the “Quality Assurance of Sterile Medicinal Products - PIC/S GMP Guide Annex 1”
  3. To enhance GMP inspection skills as well as to reduce health damages through knowledge sharing and discussion on quality assurance, etc.
  4. To exchange information and opinions with participants from PIC/S member authoritie

Date

November 12 to 15, 2019
  Nov.12
(Tue)
Nov.13
(Wed)
Nov.14
(Thu)
Nov.15
(Fri)
am - PIC/S
Seminar
PIC/S
Seminar
PIC/S
Seminar
pm PMDA-ATC
original session
PIC/S
Seminar
PIC/S
Seminar
PMDA-ATC
original session

Program

The draft program is here.

Scope

Manufacturing process of Sterile Medicinal Products

Who should apply

  • Inspectors from regulatory authorities at beginner or intermediate level
  • The person who is going to attend PIC/S Committee Meeting cannot apply
  • The training will be provided in English (with consecutive translation in some sessions).

※ All participants are expected to actively participate in all of the sessions

Registration (Registration is closed)

Number of participants: approx. 15
Registration request should be made by filling in all the necessary items including signature by Head of Organization on the application form (attached). Please send the form in both the Word file (without signature) and the PDF file (with signature) by e-mail to the e-mail address shown in “Contact Us” below.
Registration will close on July 30, 2019.

Early registration is recommended. After the close of registration, we are not able to accept change or addition of participant(s) in principle. Please be sure to allow enough time to arrange for the trip and obtain visa for entry to Japan.
If the number of applications exceeds the capacity, the number of participants from each country may be limited. Selection of participants may take place according to their organization PIC / S membership status, current work, work experience and expectations for this training course.

Confirmation of the acceptance and additional information including detailed procedure to register for the PIC/S seminar will be sent to the approved participants after the close of registration.
Please do NOT register for the PIC/S seminar before participation of "PMDA-ATC GMP Inspection Seminar 2019" is confirmed with PMDA-ATC.
 
The outline of the procedure for approved participants is as follows:

  1. Receive email from PMDA about acceptance for "PMDA-ATC GMP Inspection Seminar 2019."
  2. Following PMDA-ATC secretariat instructions, register for PIC/S seminar by 31st August 2019 and pay for the fee. Early rate is applied. Please refer to the PIC/S site. http://pics-toyama.com/registration/index.html
  3. Submit following documents to PMDA-ATC secretariat by email.
  • a certificate of participation and payment for the PIC/S seminar
  • commitment form for participants of "PMDA-ATC GMP Inspection Seminar 2019"
  • copy of your passport

Fee

PMDA-ATC will cover the travel fee according to our internal rules. Information on flight and hotel reservation assistance will be announced to the approved participants.
Payment for PIC/S Seminar registration fee is required. For further details regarding the PIC/S Seminar, please visit http://pics-toyama.com/index.html

Location

The Seminar will be held at Toyama City, Toyama prefecture, Japan.
Visit this site for detailed information on traveling to Toyama prefecture.

http://www.pref.toyama.jp/english/get_to.html

Contact us

Secretariat, PMDA Asia Training Center
E-mail: PMDA-ATC●pmda.go.jp
Office of International Cooperation
Pharmaceuticals and Medical Devices Agency
 (Note: For the purpose of security, @ in the e-mail addresses are replaced with ●. Please replace ● with @ when you send an e-mail.)

JCN 3010005007409

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

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