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National and International GCP Symposia

Posted by: , Posted on: - Categories: Compliance matters, Events and symposia, Good clinical practice

The MHRA GCP Inspectorate Symposium was held on the 5 and 6 September and opened to a ‘packed house’ of delegates. Both days were a sell-out with almost 400 delegates in total plus 100 more on the waiting list. The GCP team were very pleased to be joined at the Symposium by 4 FDA colleagues including Jean Mulinde who provided the FDA perspective on Unblinding ‘Let me count the ways!’, along with Gail Francis giving the MHRA perspective on this important issue.

We were also joined by colleagues from the Brazilian authority ANVISA and the Israeli Ministry of Health, demonstrating the international appeal of our symposia.

Scrabble pieces displaying the word 'plan'.

Other topics covered included quality systems and effective CAPA by Jason Wakelin-Smith, computer system validation with the unique spin of how it links to football(!) by Balall Naeem, a Reference Safety Information update and workshop by Beatrice Panico from CTU and Jenny Martin, IMP case studies and root cause analyses by Mandy Budwal-Jagait plus an update on the strategic review of GCP inspections in light of new technologies in clinical trials by Paula Walker.

Immediate social media feedback was extremely positive - a very successful couple of days and well worth all of the hard work that the GCP team put into the event.

We are pleased to announce that on 23 and 24 October the FDA and The MHRAMHRA will be hosting a joint GCP Workshop titled ‘Data Integrity in Global Clinical Trials – Are we there yet?’. This is a 2 day event in Silver Spring, Maryland, USA and places are limited – register in person or virtually.

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  1. Comment by Carole Jenkins posted on

    It would be helpful for those of us who were unable to attend to have sight of the presentations or summaries of the key points. Can these be made available please.

    • Replies to Carole Jenkins>

      Comment by Sara Berry posted on

      Dear Carole, A follow-up event may take place due to numbers on the waiting list. We are unable to circulate the presentations, however key points will be available in future posts on the inspectorate blog such as CSV and RSI Part 3 and have already been covered in published posts e.g. RSI Parts 1&2.
      Thanks Sara

  2. Comment by Catherine Lisles posted on

    As it is not possible to circulate the presentations - could there be a blog post from Jason on effective CAPA perhaps?

    • Replies to Catherine Lisles>

      Comment by Sara Berry posted on

      Dear Catherine, There are a number of posts related to areas that were covered in the symposium in the planning and the request for Jason's has been noted. The recent post on sponsor oversight may also be useful to you, part 2 of this will be posted in the next couple of weeks. Kind Regards Sara