Clinical Trial Regulation Conference

This conference provides a forum for information exchange and discussion on conceptual and practical questions about critical issues affecting sponsors and Member States regarding the implemention the regulation.

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SESSION 3: TECHNICAL ISSUES

Session Chair(s)

Judith Creba, PhD

Sr. Global Program Regulatory Director, Reg Affairs GDD Region EU, Novartis Pharma AG, Switzerland

Speaker(s)

Annex VI: Discussion of the Key Issues and How to Address Them

Sini Eskola, MPharm, MS, MSc

Head of International Regulatory Policy and Innovation, Takeda, Belgium

Implementation Guidance and Delegated Acts - Awareness of and the Key Identified Issues from the Draft Guidance

Isabelle Clamou

Policy Officer, DG SANTE Unit D2, European Commission, Belgium

Maja Leon-Grzymkowska

Legal Officer at European Commission, European Commission, Belgium