Happy New Year! Having pestered my team for ideas for the blog and articles it seems only fair I start 2016 by writing one myself, with a focus on stakeholder engagement and the new EU Clinical Trials Regulation update.
My name is Paula Walker and I am the GCP Inspectorate Operations Manager, and also a Senior GCP Inspector. I have worked for the agency for almost 7 years, and have been an operations manager since 2013. Due to the wide range of organisations and types of trials conducted within the UK, no 2 days in this job are ever the same. As well as inspecting clinical trials, another part of a GCP inspector’s role is engaging with stakeholders to provide advice on the clinical trials regulations, as well as disseminating the best practice we see in the many organisations that we inspect.
In 2015, the GCP team gave over 40 external presentations to a wide range of stakeholders, including commercial conferences and non-commercial events, as well as our own GCP symposium (which last year we held twice due to demand).
We look forward this year to engaging in further dialogue with you as we continue to move towards preparations for the new EU Clinical Trials Regulation. The latest information about the regulation confirms the expected implementation date to be October 2018 so there is still plenty of time to prepare!
We have many ways of communicating with you, including our MHRA GCP Forum, which you can use as a source of information on our frequently asked questions (the yellow sticky notes), as well as a forum for discussion on GCP topics. We will also be using this blog as an additional way to communicate new guidance, news and advice.
Coming up in the near future will be blogs on reference safety information and a series on the risk proportionate approach to clinical trials, which will incorporate some of the problems we see in these areas on inspection. If you have any ideas on topics you would like to see us cover please do let me know by emailing Paula.Walker@mhra.gsi.gov.uk and we will certainly consider them.
Our next Stakeholder Engagement Meeting (StEM) is planned for 18 March 2016 so we look forward to seeing those of you then that represent our key stakeholders. We also have another GCP symposium planned for around June 2016 so there is a lot to look forward to this year.
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Check out our guidance on good practice for information on the inspection process and staying compliant.
2 comments
Comment by Tony Hewer posted on
Please could you provide a link to more information about the Stakeholder Engagement Meeting (StEM) especially in terms of becoming engaged.
Comment by Paula Walker posted on
StEM was established in October 2013 and meets annually, replacing the previously separate Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GPvP) and Good Laboratory Practice (GLP) Consultative Committees. The terms of reference of the meeting are to provide a forum for discussion on key topical issues facing stakeholders, and to advise and provide information to representatives of trade associations and government departments on aspects of GCP, GPvP and GLP and associated inspections. Further information on thee StEM meeting will be uploaded onto our gov.uk site soon.