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PDG Avocats | France | 2 Dec 2015
Improvement regarding the unique clinical trial agreement to increase actractiveness of French sites
On 17 June 2014, the Ministry of Health published on Order (Instruction No. DGOS/PF4/2014/195) establishing a unique agreement template for clinical…
PDG Avocats | France | 14 Apr 2015
Legal framework of shortage in France
Short and long-term shortages of medicinal products have been a global problem which increasingly affects the European Union since the past years. In…
PDG Avocats | European Union | 29 Jan 2015
New requirement of a responsible person for medical device manufacturers
On 26 September 2012, the European Commission adopted two proposals for a Regulation (one on medical devices and in parallel one for a Regulation on…
PDG Avocats | European Union | 3 Apr 2014
Adoption of new EU clinical trial regulation
EU Regulation on clinical trials on medicinal products for human use (the Regulation) was adopted by the EU Parliament on 2 April 2014. This…
PDG Avocats | European Union, France | 19 Mar 2014
French implementation of the EFPIA Code on disclosure of transfers of value in the light of the French Sunshine Act
During the second part of 2011, the French government decided to review the current French Health Product system following the Mediator scandal. Law…
PDG Avocats | France | 13 Mar 2013
Data health hosting: how far are we?
The private and public hospitals ("hospitals") and the physicians produce every day a big amount of data concerning their patients. They are not…
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