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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.

SESSION 3: TECHNICAL ISSUES

Session Chair(s)

Judith Creba, PhD

Judith Creba, PhD

  • Executive Director, EU Regulatory Strategy
  • Novartis Pharma AG, Switzerland

Speaker(s)

Sini Eskola, MPharm, MSc

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

Sini Eskola, MPharm, MSc

  • Director Regulatory Affairs
  • European Federation of Pharmaceutical Industries and Associations (EFPIA), Belgium
Isabelle Clamou

Implementation Guidance and Delegated Acts - Awareness of and the Key Identified Issues from the Draft Guidance

Isabelle Clamou

  • Regulatory affairs Director - EU Policy
  • Amgen Ltd, Belgium
Maja Leon-Grzymkowska

Maja Leon-Grzymkowska

  • Legal Officer at European Commission
  • European Commission, Belgium

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