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Session 6: Answers to Your Burning Questions from the EMA Representatives
Session Chair(s)
Merete Joergensen, MBA, MSc
Clinical Disclosure and Transparency Expert
Merete-J Consulting, Denmark
We are all industry and regulators on the road to implement the new requirements aiming for more transparency. During the last days a lot of information on the EMA policy 0070 and the EU Clinical Trial Regulation have been presented. Now is your chance to bring back home the answers to the burning questions you are struggling to find the answers to. And also to learn from the questions your peers have on the challenges they are or have been facing when implementing the new requirements. Use the opportunity to ensure you can bring back the latest for continued discussions in your own environment on which strategy you should be choosing in order to best be prepared for what is coming.
Speaker(s)
Anne-Sophie Henry-Eude, PharmD
European Medicines Agency, Netherlands
Head of Documents Access and Publication Department
Aleksandar Rusanov
European Medicines Agency, Netherlands
Legal Adviser
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