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New requirement of a responsible person for medical device manufacturers

January 29 2015 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…

French implementation of the EFPIA Code on disclosure of transfers of value in the light of the French Sunshine Act

March 19 2014 During the second part of 2011, the French government decided to review the current French Health Product system following the Mediator scandal. Law…

Legal framework of shortage in France

April 14 2015 Short and long-term shortages of medicinal products have been a global problem which increasingly affects the European Union since the past years. In…

Improvement regarding the unique clinical trial agreement to increase actractiveness of French sites

December 2 2015 On 17 June 2014, the Ministry of Health published on Order (Instruction No. DGOS/PF4/2014/195) establishing a unique agreement template for clinical…

Data health hosting: how far are we?

March 13 2013 The private and public hospitals ("hospitals") and the physicians produce every day a big amount of data concerning their patients. They are not…

Improvement regarding the unique clinical trial agreement to increase actractiveness of French sites

December 2 2015 On 17 June 2014, the Ministry of Health published on Order (Instruction No. DGOS/PF4/2014/195) establishing a unique agreement template for clinical…

Legal framework of shortage in France

April 14 2015 Short and long-term shortages of medicinal products have been a global problem which increasingly affects the European Union since the past years. In…

New requirement of a responsible person for medical device manufacturers

January 29 2015 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…

Adoption of new EU clinical trial regulation

April 3 2014 EU Regulation on clinical trials on medicinal products for human use (the Regulation) was adopted by the EU Parliament on 2 April 2014. This…

French implementation of the EFPIA Code on disclosure of transfers of value in the light of the French Sunshine Act

March 19 2014 During the second part of 2011, the French government decided to review the current French Health Product system following the Mediator scandal. Law…