DIA Global Clinical Trial Disclosure and Data Transparency Conference

This virtual live conference is a must-attend for anyone involved in clinical trials!

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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)

Laura Pioppo, MSC

ACT EU Programme Manager, European Medicines Agency, Netherlands

Opening

Marianne Lunzer, DrMed

Assessor, Dept of Clinical Trials, Federal Office for Safety in Health Care, AGES, Austria

Member States /CA Perspective

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