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)

Opening

Laura Pioppo, MSc

European Medicines Agency, Netherlands

Scientific Administrator, CTIS expert

Member States /CA Perspective

Marianne Lunzer, DrMed

AGES, Austria

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

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