Calendar

9 - 11 November 2021

PIC/S Virtual Seminar 2021

The Ministry of Food and Drug Safety (MFDS) of Republic of Korea is pleased to host virtually the 2021 PIC/S Seminar on “GMP Assessment Approaches in Post COVID-19 Era” on 9-11 November 2021.

The Seminar is the main annual international training event by PIC/S which is open to GMP Inspectors from PIC/S Participating Authorities, (Pre)Applicants, Partners and non-PIC/S Member Medicines Regulatory Authorities.

Registration (only for Medicines Regulatory Authorities) is open until 15 October 2021.

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25 - 26 November 2021

Japan / PMDA - ATC GMP Inspection Webinar 2021 with the support of PIC/S

This Webinar is organised by Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs (PMDA-ATC), with the support of PIC/S. It will take place on 25-26 November 2021. The focus of the Webinar is to offer practical training on GMP Regulation and Quality Risk Management (QRM). It will be held virtually and include live presentations, Q&A and group discussions.

The Webinar is not open to the industry or non-Regulatory Authorities. For more information watch this introductory video. Registration is open until 23 September 2021 (only for Medicines Regulatory Authorities), see link below for more information.

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15 - 16 December 2021

PIC/S Expert Circle on Cross-Contamination in Shared Facilities (CCCISF) Meeting

The Inspection Services of the Prequalification Unit, World Health Organization (WHO)  is pleased to host the second PIC/S Expert Circle on Cross-Contamination in Shared Facilities (CCCISF) meeting to be held virtually, on 14-15 December 2021.

The meeting is designed to share and develop an understanding of challenges facing inspectors on inspection of risk of (chemical) cross-contamination in shared facilities and the inspection approaches required to successfully inspect for compliance with PIC/S GMP. A number of specific topics will be addressed. The Expert Circle meeting is open to PIC/S Participating Authorities, Partners, (Pre) Applicants and non-Member Medicines Regulatory Authorities. Deadline for registration is 22 October 2021.

For more information, please contact the PIC/S Secretariat.

Past events

11 May 2021

PIC/S Webinar for Inspectors Training on ICH Q12

The PIC/S Working Group on Training Material for ICH Q12 is pleased to host a Webinar for PIC/S Inspectors Training on ICH Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management on 11 May 2021.

The focus of this Webinar is to allow Inspectors to discuss training and draft tools developed by the PIC/S Working Group in order to facilitate and accompany implementation of ICH Q12. 

The Webinar is open to PIC/S Participating Authorities, Partners and (Pre)Applicants. For information on registration, please contact the PIC/S Secretariat.

8 - 10 December 2020

PIC/S Virtual Seminar 2020

The Finnish Medicines Agency (FIMEA) is pleased to host virtually the 2020 PIC/S Seminar on “Distant Assessment of GMP Compliance" on 8-10 December 2020.

The Seminar is the main annual international training event by PIC/S which is open to GMP Inspectors from PIC/S Participating Authorities, (Pre-)Applicants, Partners and non-PIC/S Member Medicines Regulatory Authorities.

Registration (only for Medicines Regulatory Authorities) is open until 8 November 2020.

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24 September 2020

PIC/S Expert Circle on Quality Risk Management (QRM) Webinar

The Turkish Medicines and Medical Devices Agency (TMMDA) is pleased to host virtually by webinar the next PIC/S Expert Circle on Quality Risk Management (QRM) meeting on 24 September 2020.

Due to the COVID-19 situation, TMMDA has taken the decision to postpone the hosting of the QRM Advanced Training event planned on 22-24 September 2020 in Istanbul (Turkey). The new dates for the QRM Advanced Training event in Istanbul will be planned for the second half of 2021. The meeting of the Expert Circle of QRM will go ahead as a webinar on 24 September 2020 hosted by Turkey / TMMDA. The webinar will have some training elements of QRM. The webinar is open to regulatory authorities-only i.e. PIC/S Participating Authorities, Partners, (Pre)Applicants and non- PIC/S Member Medicines Regulatory Authorities.

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