Date: February 7, 2018
Mintz Levin Health Law attorney, Bethany Hills, will moderate the second part of a two-part webinar series titled, "Conducting Multi-Jurisdictional Trials: Understanding Changes in the US and EU Part ll." This webinar will be conducted by Portolano Cavallo attorneys and will cover the following topics:
- The Clinical Trials Regulation No. 536/2014 and its impact on the previous legislation
- The EU Portal and Database: a new coordinated procedure to authorize clinical trials in Europe and to enhance transparency of clinical trials results
- Other main news introduced by Regulation No. 536/2014 concerning: (i) retention policy of the Trial Master File; (ii) co-sponsorship; and (iii) informed consent
- The processing of personal data (in particular health and genetic data) for scientific research purposes under the General Data Protection Regulation No. 679/2016
- The updated timelines for the application of the new Regulation No. 536/2014 and the transition period
For more information on this webinar and to register, please click here.