Home » Events » 🇬🇧 Interactive GCP Refresher Training for Investigators & Site Personnel
🇬🇧 Interactive GCP Refresher Training for Investigators & Site Personnel
15 June, 2022
The planning, preparation and reporting processes of clinical trials are currently undergoing major changes. COVID-19 induced emergency measures towards decentralization of study activities enabled by regulatory guidelines on EU and national levels will partly remain after the end of the pandemic as some of the new processes turned out to be beneficial to the decrease of burden to study participants. The now enforced Clinical Trial Regulation EU 536/2014 will enforce a faster and harmonized clinical trial authorisation system but will also introduce the systematic involvement of patients into the clinical trial activities. Major efforts have been made by the European Commission, EMA, pharmaceutical companies and patient organisations to enable educated patient capacity and governance infrastructure to make such collaboration work efficiently. Also academic institutions need to be aware of these new requirements and work out efficient ways to benefit from such patient input in their resource-constrained research infrastructure.
In this GCP-Refresher course areas of obligatory and voluntary patient involvement in the clinical trial process will be presented. Suitable tools for defining the patient profiles needed and for gathering patient input according to the type of research planned will be explained. An overview on mutually accepted governance and contractual templates as well as strategies for finding suitable and collaborative patients will be explained.
MD, PhD, FFPM, FBCPM Expert in Drug Development Planning and Site Management Support, Pharmaplex bv, Brussels, Belgium & Chairman of the Board of European Forum for Good Clinical Practice (EFGCP)
MSc Luxembourg Institute of Health (LIH), Engagement and Communication Officer. EUPATI Board Member, EUPATI Fellow, Chair of EUPATI Luxembourg.
13:00 Welcome and Introduction to the patient organisations landscape
13:15 Patient involvement: why, when and what?
13:45 Consultative and collaborative mechanisms
14:10 Key areas for involvement: protocol design, informed consent, lay summary preparation
14:30 Defining the patient profiles needed
15:00 Helpful patient involvement guidance and governance tools
15:30 Coffee Break
15:50 Exercise in break-out sessions: How to plan patient involvement in a clinical trial that will start in January 2023?
16:40 Plenary discussion of the Exercise results
17:00 Final multiple-choice test
17:30 Delivery of certifications / End of the Training
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