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 9: EMA Policy 0070: Challenges and Techniques for Sponsors

Session Chair(s)

Merete Joergensen, MBA, MSC

Clinical Disclosure and Transparency Expert, Merete-J Consulting, Denmark

Speaker(s)

Nicole Hinton

Executive Director, Clinical Trial Transparency, Ultragenyx, United States

Industry Experience with Preparing Documents for Submission

Mats Ericson, PHD

Director Regulatory Affairs, Amgen, France

Janice Branson, MSC

VP Head of Statistics, Immunology & Dermatology Unit, Novartis Pharma AG, Switzerland

Technical Solutions to Ease the Process of Redaction/ Anonymisation/Justification

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