PIC/S - Press release and news of TFDA hosted meetings and seminar, September 2017

From 11 to 15 September 2017 I attended the PIC/S Committee meeting, Executive Bureau meeting, and Annual Seminar hosted by the Taiwan Food and Drug Administration (TFDA)

The main highlights from the meetings were:

  • New PIC/S Chairman for 2018
  • New Executive Bureau and new Sub-Committee Members for 2018-2019
  • Iran / IFDA, Turkey / TMMDA and Mexico / COFEPRIS join PIC/S
  • PIC/S 2017 Seminar On "Quality Control Laboratories: How To Inspect" Hosted By Chinese Taipei / TFDA draws more than 170 inspectors from 50 countries
  • Saudi Arabia / SFDA as well as Russian Federation / Minpromtorg & FSI SID&GP apply for Pre-Accession; Armenia / SCDMTE applies for Accession
  • PIC/S Vision And Perspectives for 2018-2020
  • New tool and framework to strengthen reliance and maximise resources for GMP compliance of overseas facilities
  • Continued concerns with draft EU GMP Guidelines For ATMPs
  • Latest PIC/S developments in the field of GM(D)P harmonisation

The full press release can be found here and more info on PIC/S here

MHRA participation

Paul Hargreaves from the MHRA has been the PIC/S Chairman since the start of 2016 and under Paul's leadership both the Executive Bureau and Committee meeting where held on the 11 and 12 September.  I attended to represent the MHRA at the meetings.

The PIC/S 2017 Seminar On "Quality Control Laboratories: How To Inspect" was held on 13 to 15 September and included presentations given by Paul and also Lesley Graham of MHRA.  Additionally, Lesley and I ran a workshop on dealing with out of specification and out of trend laboratory results.  The outcomes of this workshop will be the subject of another post later this year on the blog.

The ICMRA framework that is highlighted in the press release has been developed over the last 3 years by an international team of regulators, led by MHRA.

Overall, the meeting was invaluable for maintaining our working relationships with many of our international partners and ensuring that MHRA is at the forefront of driving regulatory thinking.

Paul Hargreaves gives the opening address of the PIC/S 2017 Seminar
Lesley Graham presents on OOS/OOT
TFDA hand over the PIC/S walking stick to USFDA, the hosts of the 2018 Seminar, accompanied by current and future chairman
PIC/S walking stick

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