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Millennium Hotel London Mayfair

Dec 06, 2017 12:30 PM - Dec 07, 2017 4:45 PM

44 Grosvenor Square Mayfair, London, W1K 2HP, United Kingdom

The Evolution of Policy 0070: EMA Clinical Data Publication

Session 6: Answers to Your Burning Questions from the EMA Representatives

Session Chair(s)

Merete  Joergensen, MBA, MSc

Merete Joergensen, MBA, MSc

Clinical Disclosure and Transparency Expert, Former EFPIA, CREG Clinical Trials

Merete-J Consulting CVR: 34920818, 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

Anne-Sophie Henry-Eude, PharmD

European Medicines Agency, Netherlands

Head of Documents Access and Publication Department

Aleksandar   Rusanov

Aleksandar Rusanov

European Medicines Agency, Netherlands

Legal Adviser

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