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Session 4: CTIS with One Transition Year Ahead: The Revised CTIS Transparency Rules
Session Chair(s)
Scott Feiner
Senior Manager, Trial Disclosure
AbbVie, United States
Ruediger Pankow, DRSC
Clinical Trial Regulatory Consultant | CTIS SME
Independent Consultant, Germany
Overview of the July 2023 EMA Guidance document on how to approach the protection personal data (PPD) and commercial confidential information (CCI) in CTIS by EMA, with updates from Member States and Ethics Committees perspective on the implementation of this latest guidance.
Speaker(s)
Opening
Laura Pioppo, MSC
European Medicines Agency, Netherlands
ACT EU Programme Manager
Member States /CA Perspective
Marianne Lunzer, DrMed
AGES, Austria
Assessor, Dept of Clinical Trials, Federal Office for Safety in Health Care