Paule Drouault-Gardrat

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

France - 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…

Juliette Peterka

Legal framework of shortage in France

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…

Juliette Peterka

New requirement of a responsible person for medical device manufacturers

European Union - 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…

Juliette Peterka

Adoption of new EU clinical trial regulation

European Union - 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…

Juliette Peterka

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

European Union, France - 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…

Juliette Peterka