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EFGCP Summer Workshop

Proactive inspection readiness - anticipating future regulatory changes

Description

Event Workshop
Type Virtual Event
Language English
Date(s) Q3 2023
Day(s) 1 Day(s)
Duration 1 Day

The Workshop will be held virtually and is postponed to Q3 2023. The date will follow as soon as possible.

This interactive, practical workshop will feature a range of speakers on topics including Investigational Medicinal Product Management, consent, and a shared workshop on decentralised clinical trials.

    Working in groups, we’ll look at different aspects of decentralised trials and practical considerations from those ‘in the know’ and those ‘wanting to know’. 

    So, whether you have experience in decentralised clinical trials or not, your contributions, experience, curiosity and innovation can be brought to discussion of:

    • Sponsor Oversight
    • Investigator Oversight
    • Quality Assurance & Audit
    • Operational Considerations

    Each group will share its outputs with the whole group before a final wrap up, questions and answers.

    Programme

    Q3 2023
    10:30 Workshop Opening
    11:15 Welcome & Introductions
    11:30 CTD to CTR – Implications for Investigational Medicinal Product (IMP) Management to Ensure Regulatory Compliance
    Michelle Yeomans, EPIC Auditors
    Overview of IMP regulatory requirements and top tips for achieving compliance.
    12:00 Clinical Trials, Inspections and Computerised Systems
    Speaker TBD,
    Review of regulatory changes such as the implementation of, and practical experience with, the Clinical Trial Regulation in Europe, UK Clinical Trial Regulations, electronic data and data integrity considerations for clinical trials, recent inspection experiences and inspection findings
    13:15 Lunch
    14:00 Upcoming regulatory changes and potential considerations for the implementation of ICH GCP (R3)
    Speaker TBD,
    14:30 Practical ideas to improve consent by putting the patient at the centre of our considerations
    Hugh Davies, Chair of Oxford “A” National Health Service Research Ethics Committee
    15:00 Decentralised Clinical Trials Workshop
    16:30 Workshop Feedback
    17:15 Panel Session, Final Q&A
    18:00 Close