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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, Former EFPIA, CREG Clinical Trials
Merete-J Consulting CVR: 34920818, 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
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 Department
European Medicines Agency, Netherlands
Challenges Protecting Sponsors’ Commercial Interests and Patients’ Privacy (Legal/Patent Attorney/Data Privacy): Marie Manley
Partner, Head of EU and UK Life Sciences (UK)
Sidley Austin LLP, United Kingdom
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