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, Former EFPIA, CREG Clinical Trials

Merete-J Consulting CVR: 34920818, Denmark

Speaker(s)

Industry Experience with Preparing Documents for Submission

Nicole Hinton

Ultragenyx Pharmaceutical, United States

Sr Director, Clinical Trial Transparency

Mats Ericson, PhD

Amgen, France

Director Regulatory Affairs

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

Janice Branson, MSc

Novartis Pharma AG, Switzerland

VP Head of Statistics, Immunology & Dermatology Unit

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