In March 2012, the UK MHRA and Department of Health issued alerts informing the public of information from the AFSSAPS
suggesting that PIP implants manufactured prior to 2001 might, like the later PIP implants, contain unauthorized silicone filler.
In the case of the Mediator, the Medicines Agency imposed the removal while the AFSSAPS
was responsible for announcing the decision on November 25, 2009.
The 175-page AFSSAPS
report was released yesterday.
Boutrand has been involved in more than 60 public presentations or publications on topics related to medical device evaluation and is registered as an expert on the biological safety of medical devices for the AFSSAPS
Philippe Arnaud (Pharmacien des Hopitaux, Chef de Service, Hopital Bichat-Claude Bernard APHP, Expert AFSSAPS
Measures taken by selected regularly agencies before and after licensing to assess and control antimicrobial drug resistance * Measure Australia France Therapeutic Goods AFSSAPS
(french Administration, health products Australian safety agency), Commission for Primary drug Drug Evaluation Marketing registration body Committee Authorization Drug resistance advisory EAGAR GTA, CA-SFM, ONERBA resource Licensing Use of supportive Yes Yes PK/PD data Risk assessment Yes Yes After licensing Prescription-only Yes Yes status Community drug Yes No subsidy restrictions Participation in education Yes Yes (e.
After recalling the principles for awarding the Pharmapack prizes and thanking the jury, Prof Philippe Arnaud, Faculte de Pharmacie, Universite Paris V Rene Descartes, Pharmacist, Hopital Bichat, AFSSAPS
expert, pointed out: As for the awards at previous editions, the jury members, who are independent, have singled out packaging/drug duos placed on the French market between the 1st January and the 31st December 2007, taking all the categories into account and, in particular, medical devices, which are real driving forces behind innovation in the pharmaceutical sector.
Vincent Gazin then Head of the Clinical Toxicology Unit, AFSSAPS
voiced support for a science based risk-management method at the 2008 ISPE Washington Conference.
The Hyderabad facility has been inspected and approved by various regulatory agencies like DCGI, ANVISA-Brazil, MoH (Turkey), FDA, AFSSAPS
(France), WHO and MHRA.
ANSM: National Security Agency of Medicines (Agence Nationale de Securite du Medicament), which is set to replaces AFSSAPS
In February 2012, the Offices of the French medicines agency, AFSSAPS
, were searched by investigators after it allowed the sale of diabetes drug Mediator (benfluorex).
National Security Agency of Medicines (l'Agence Nationale de Securite du Medicament), which is set to replaces AFSSAPS