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.  


Trainers

  • Ingrid
    Klingmann

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)

  • Sandrine
    Lavallé

MSc
Luxembourg Institute of Health (LIH), Engagement and Communication Officer. EUPATI Board Member, EUPATI Fellow, Chair of EUPATI Luxembourg.


AGENDA

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

INFORMATION & REGISTRATION

Tania
Zamboni

Pricing

C1: free
LIH / IBBL / Students / LCSB / National hospitals / National healthcare professionals / Researchers / PI / National academia

C2: 100 €
International academia

C3: 200 €
Private companies

WHERE

Centre Hospitalier de Luxembourg – Amphitéater
4 Rue Nicolas Ernest Barblé
1210 Luxembourg
Luxembourg

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