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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)
Practicalities of using CTIS in the Future
Ruediger Pankow, DRSC
Independent Consultant, Germany
Clinical Trial Regulatory Consultant | CTIS SME
Operational Considerations of an Academic Institution or a Small Sponsor
Andrea Seidel-Glaetzer, MA, RN
Coordination Centre For Clinical Trials Heidelberg (KKS), Germany
Head of Project Management
Operational Considerations of Large Organisation
Pierre-Frederic Omnes, MPHARM
TransPerfect, France
Executive Director, Life Sciences