This seminar is hosted by MHLW and PMDA

Welcome Remarks

PIC/S Committee Meeting and Seminar
“Quality Assurance of Sterile Medicinal Products -PIC/S GMP Guide Annex1”-
Toyama, JAPAN
11 to 15 November, 2019

Tokyo; 17 April, 2019

Dear Colleagues,

Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) have honor to announce that registration is now open for the PIC/S Committee Meeting and Seminar, hosted by MHLW and PMDA from 11 to 15 November, 2019 in Toyama, JAPAN.

The Seminar, entitled “Quality Assurance of Sterile Medicinal Products - PIC/S GMP Guide Annex1-” will consist of interactive discussions, presentations, and workshops.

This seminar is intended to provide a further understanding of the PIC/S GMP Guide Annex1 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 how to make science and risk based decisions related to product quality during GMP inspections. It is an ideal opportunity for both novice and experienced inspectors to enhance their inspection skills through knowledge sharing and discussion.


The total duration of the Committee Meeting and Seminar is 4.5 days and is scheduled as follows:

  • 0.5 day for PIC/S Executive Bureau (EB) Meeting (11 November(Monday) morning, for EB members-only)
  • 1.5 days for PIC/S Committee Meeting (11 November (Monday) afternoonand 12 (Tuesday) full day)
  • 2.5 days for the Seminar (13 November (Wednesday) full day, 14(Thursday) full day, and 15 (Friday) morning)

After the Seminar, an optional half-day excursion (15 (Friday) afternoon) will be planned for your charge. You can visit the World Heritage “Gokayama Historic Village” (http://gokayama-info.jp/en/) in Toyama if you would like.

The Seminar is open to the participation of inspectors from Medicines Regulatory Authorities from around the world. For registration and further details regarding the Seminar, please visit http://pics-toyama.com/.

Registration will operate on a first-come, first-served basis. The number of participants is subject to capacity and is in compliance with PIC/S rules on fair and equal representation, therefore please be sure to register as soon as possible. The deadline for registrations is 31 October, 2019, with the early bird rate expiring on 31 August, 2019.

The PIC/S Committee Meeting and Seminar will be held at the ANA Crowne Plaza Toyama, located in downtown Toyama. Should you wish to book accommodation at the venue, a limited number of rooms have been reserved. Please visit the “Hotel and Accommodations” tab on the conference website.

For any questions about 2019 PIC/S Seminar venue and other relevant practical details, please email us at: pics2019japan@pmda.go.jp


Sincerely yours,


森 和彦
Kazuhiko Mori
Councillor
Minister’s Secretariat
Ministry of Health, Labour and Welfare


NOTE:This is a closed event for Regulators only. Non-regulators will not be considered and should not register.
25 April, 2019