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)

Sini Eskola, MPHARM, MS, MSC

Head of International Regulatory Policy and Innovation, Takeda, Belgium

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

Isabelle Clamou

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

Implementation Guidance and Delegated Acts - Awareness of and the Key Identified Issues from the Draft Guidance

Maja Leon-Grzymkowska

Legal Officer at European Commission, European Commission, Belgium

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