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SESSION 8: EMA POLICIES 0070: FIRST EXPERIENCES AND IMPLICATIONS
Session Chair(s)
Session Chair
Session Chair, United Kingdom
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)
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)