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 8: EMA POLICIES 0070: FIRST EXPERIENCES AND IMPLICATIONS

Session Chair(s)

Merete Joergensen, MBA, MSc

Clinical Disclosure and Transparency Expert

Merete-J Consulting, Denmark

You will hear about the rules for Policy 70, and the experiences with it so far, followed by discussions how the policy can translate into actual data availability under the CTReg views from other groups (lawyers, medical affairs, CROs, payers, academics)

Speaker(s)

Anna Gross, PhD

European Medicines Agency, Netherlands

Grant Strachan, LLM

Brodies LLP Solicitors Capital House, United Kingdom

Senior Associate, Regulatory

EMA Perspective on Policy 0070 and 0043: First Experience of Phase 1 (Submission of Clinical Reports) and Plans for Phase 2 (Submission of IPD), Similarities and Differences in Implementation

Anne-Sophie Henry-Eude, PharmD

European Medicines Agency, Netherlands

Head of Documents Access and Publication Department

Challenges Protecting Sponsors’ Commercial Interests and Patients’ Privacy (Legal/Patent Attorney/Data Privacy)

Marie Manley

Sidley Austin LLP, United Kingdom

Partner, Head of EU and UK Life Sciences (UK)

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