The General Data Protection Regulation (GDPR) will come into effect in the spring of 2018, replacing the Data Protection Directive 95/46/EC. A new Regulation on Clinical Trials - Regulation (EU) No 536/2014 – is likely to enter into application in the meantime. Besides, the new EU-US Privacy Shield has entered into full operation on the 1st of August 2016. Finally, the Belgian Government is still working on its Biobanking decree.
All these legislative changes have a considerable impact on research activities in general, and on sample management, biobanking and clinical trials in particular. Not only pharma and biotech companies are concerned by these measures but also medical devices companies, companies involved in m-health and e-health, CRO's, universities as well as hospitals.
In that context, we invite you to take part to a seminar that will assess, in an interactive and practical approach, the legal, strategic and operational changes that these measures will trigger.
Nour de San is Medical Doctor with a specialisation in Clinical Biology and has been Head of Risk Management and Learning - Vaccines Discovery and Development at GSK as well as Head of GSK's Biobank following which she led GSK's Vaccines Data Integrity and Information Protection Program. She is now independent consultant and helps companies in change management.
Marc Martens is Co-head of Bird & Bird's international Life Sciences and Healthcare group and has a longstanding experience in all regulatory matters for pharmaceutical, biotech and medical devices companies. He is also member of the board of Bio.be.
Would you like to attend?