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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 8: EMA POLICIES 0070: FIRST EXPERIENCES AND IMPLICATIONS

Session Chair(s)

Merete  Joergensen, MBA, MSc

Merete Joergensen, MBA, MSc

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

Anna Gross, PhD

  • European Medicines Agency, Netherlands
Grant  Strachan, LLM

Grant Strachan, LLM

  • Senior Associate, Regulatory
  • Brodies LLP Solicitors Capital House, United Kingdom
Anne-Sophie  Henry-Eude, PharmD

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

  • Head of Documents Access and Publication Service
  • European Medicines Agency, Netherlands
Marie  Manley

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

Marie Manley

  • Associate, Life Sciences
  • Sidley Austin LLP, United Kingdom

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+41 61 225 51 51


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+41 61 225 51 49