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Session 4: 1 Year Countdown: Are You Ready? Sponsors preparedness for CTR including non-commercials sponsors
Session Chair(s)
Rose-Marie Swallow
Senior Manager, Policy & Research, Bayer Plc., United Kingdom
This session will present the thoughts of three Sponsor Product Owners who are working with EMA and the IT Developers preparing CTIS for audit and then go-live on: how things are proceeding, what practicalities Sponsors of all types and sizes might need to consider in this final countdown stage; and what tips and pitfalls they might want to consider when preparing for the implementation of the CTR in late 2021.
Speaker(s)
Ruediger Pankow, DRSC
Clinical Trial Regulatory Consultant | CTIS SME, Independent Consultant, Germany
Practicalities of using CTIS in the Future
Andrea Seidel-Glaetzer, MA, RN
Head of Project Management , Coordination Centre For Clinical Trials Heidelberg (KKS), Germany
Operational Considerations of an Academic Institution or a Small Sponsor
Pierre-Frederic Omnes, MPHARM
Executive Director, Life Sciences, TransPerfect, France
Operational Considerations of Large Organisation
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