As part of my role as GCP Operations Manager and Lead Senior GCP Inspector, I am working with Mandy Budwal-Jagait (Senior GCP Inspector) on this year’s GCP Symposium, which will be held in Manchester on 11 September 2019. This symposium is primarily aimed at non-commercial organisations. The symposium will be exploring hot topics relevant not only to non-commercial sponsors, but also to investigator sites for all clinical trials involving investigational medicinal products (IMP).
With 4 weeks to go until the symposium, I wanted to share with you the latest updates on how the programme is shaping up.
Paula Walker (Inspectorate Unit Manager & Lead Senior GCP Inspector) Gail Francis (Expert Inspector, GCP) and Morag Ross (Pharmacist Specialist, Care Quality Commission) will be kicking off the morning with an update on Electronic Health Records (EHRs), looking at the pitfalls we have identified and how we can help you ensure your EHRs facilitate GCP-compliant clinical trials.
Next, an Oversight of Investigational Medicinal Product by Jason Wakelin-Smith (Lead Senior GCP & GLP Inspector) will explore how technology is changing the management of IMP, the risks associated with the use of electronic IMP management, and prescribing systems.
Following on from this, Mandy Budwal-Jagait will conclude the morning session with a look at Investigator Oversight. This session will focus on your responsibilities as an investigator site or principal investigator (PI), looking at what you need to consider when the sponsor organises or contracts an external source to undertake some of your site activities. In addition, Mandy will be exploring what you should consider when investigator activities such as dosing have been delegated to a third party or are being performed off-site and how you demonstrate oversight.
The afternoon will commence with a presentation from Andy Fisher (Lead Senior GCP Inspector) exploring what it means for your site and the control of your data if the sponsor is providing their own systems to capture source trial data.
Beatrice Panico (Medical Assessor for the MHRA Clinical Trials Unit) and I will then be covering Safety Reporting for Non-commercial Trials. We will look at your responsibilities for safety reporting and identifying adverse events (AEs), serious adverse events (SAEs) and suspected unexpected serious adverse reactions (SUSARs). We will also review what additional sponsor responsibilities you - as chief investigator (CI) or PI - may be delegated, and how to ensure compliance with these responsibilities.
In the final session of the day, Michael McGuinness (GLP and GCP Inspector) will focus on GCP Labs, looking at what oversight you have, as sponsor or CI, for ensuring GCP compliance of any laboratories that are undertaking endpoint analyses for your trial.
As always, the sessions will be interactive and delegates will have the opportunity to ask the panel questions, as well as having chance to network and to discuss queries with inspectors during the inspectors’ surgery.
Find out more or register here.
For commercial organisations, a GCP symposium will be held in London early next year. This will be a joint venture between the MHRA and FDA. Please look out for further communications and registration details for this event in due course.
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