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 9: EMA Policy 0070: Challenges and Techniques for Sponsors

Session Chair(s)

Merete  Joergensen, MBA, MSc

Merete Joergensen, MBA, MSc

  • Senior Trial Disclosure Director, Clinical Transparency
  • Novo Nordisk A/S, Denmark


Nicole  Hinton

Industry Experience with Preparing Documents for Submission

Nicole Hinton

  • Associate Director, Clinical Trial Transparency
  • Ultragenyx, United States
Mats  Ericson, PhD

Mats Ericson, PhD

  • Director Regulatory Affairs
  • Amgen, France
Janice  Branson, MSc

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

Janice Branson, MSc

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

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+41 61 225 51 51

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+41 61 225 51 49