Brexit

• Sabrina
  11/12/2018 09:46

  Hi. As we have had a group of people working on preparations of Brexit, I wonder if there is anything that we need to think about when it comes to QA, we are looking at clinical supplies chain, clinical trials, regulatory but not sure if there is anything we can do when it comes to QA? Thank you Sabrina
• Anon
  11/12/2018 16:25

  One suggestion: vote Remain in the next referendum!
• Colin Wilsher
  17/12/2018 17:36

  It is very difficult to decide upon this as things keep developing. It could be one of the items put into your risk assessment for your audit programme. You might assume that sites or systems affected by Brexit might be adversely affected and hence might warrant a higher rating on the risk scale and hence warrant more audit attention. But as we say there is no clear indication as to what those GCP risks are. Obviously there are GMP and PV disruption with UK leaving EU. >>> The RQA GCP Com will continue to keep a close eye on this topic.
• Sabrina
  18/12/2018 16:35

  great thank you Colin, that is very helpful. Sabrina
• Eloise Britten
  07/01/2021 13:22

  Looking to put a GAP analysis in place for post Brexit Clinical Trials from a GCP perspective. Would appreciate input into the best way to tackle this as there is a lot of info in many different places.
• Anon
  07/01/2021 17:34

  Too true. MHRA issued an avalanche of new guidance one minute after 11pm when we left EU. Not sure anyone can read all that!

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