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Session 7: Transitional Trials: less than a year to get it done!
Session Chair(s)
Matthias Zerm, PhD
Lead Expert, Clinical Trial Disclosure and R&D Processes
Germany
Merete Joergensen, MBA, MSc
Clinical Disclosure and Transparency Expert, Former EFPIA, CREG Clinical Trials
Merete-J Consulting CVR: 34920818, Denmark
In case your company has ongoing trials in scope for transition, now is the time to start considering how and when to get it done. To ensure trials can continue under the regulation the transition must be completed before end of January 2025 I.e. expected latest submission September 2024. Presentations cover practical examples of transitions completed. What obstacles have sponsors/CROs met and what is important to consider when planning and performing the transitions. Use your option to ask questions directly to those who have tried it and maybe join and contribute your own experience.
Speaker(s)
Opening
Caroline Correas, MA
Switzerland
Associate Director, Global Regulatory Policy
Dos and Don’ts
Monique Al, PhD
Central Committee on Research Involving Human Subjects (CCMO), Netherlands
Special advisor CCMO
Sponsor Experience
Sameer Sharma, MPharm
Merck KGaA, Germany
Associate Director, Clinical Trial Transparency
Sponsor Experience
Chris Bamford, PhD
IQVIA Ltd, United Kingdom
Director, Regulatory Affairs
Sponsor Experience
Seán Kilbride, PhD
Regeneron Ireland DAC, Ireland
Director, Regulatory Affairs
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