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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
Senior Associate, Regulatory , Brodies LLP Solicitors Capital House, United Kingdom
Anne-Sophie Henry-Eude, PHARMD
Head of Documents Access and Publication Department, European Medicines Agency, Netherlands
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
Marie Manley
Partner, Head of EU and UK Life Sciences (UK), Sidley Austin LLP, United Kingdom
Challenges Protecting Sponsors’ Commercial Interests and Patients’ Privacy (Legal/Patent Attorney/Data Privacy)
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