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Regulatory Region - International
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EXPERT VIEW
Japan compassionate use drugs proposal faces regulatory minefield
25 April 2012
Ian Haydock
Japan is beginning to intensify political debate on a formal system for the "compassionate use" of unapproved drugs, in a move that might bring it into line with similar schemes in the US and EU. The key word is "might", as it remains far from clear ...
INTERVIEW
European generics industry throws its weight behind IMPACT
07 April 2010
Faraz Kermani
The emergence of counterfeit medicines in the European Union and indeed globally is a serious problem for the pharmaceutical industry. Generally ...
LATEST FEATURES
The PIP breast implant affair - it hasn't all been said
08 February 2012
Trevor Lewis provides some insights into the Poly Implant Prosthèse breast implant affair and makes some suggestions on what has been learnt and what still needs to change ? or not It was already a possibility that a more prescriptive, ...
What the International Medical Device Regulators Forum can do to re-energise efforts towards global regulatory harmonisation
27 January 2012
Gabriel Adusei explains how the IMDRF can build on the achievements of its predecessor, the Global Harmonization Task Force. As the International Medical Device Regulators Forum gears up for its inaugural meeting in Singapore at the end of February ...
Tackling medical software regulation
09 November 2011
Nicole Denjoy reports from a high-level conference on global developments for regulating medical device software. Standards are essential tools to support efficient regulation in all fields, no less so than in the medical technology space where ...
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MULTIMEDIA
Regulatory Affairs Medtech News Roundup, December 2010
09 December 2010
PEOPLE
Saudi FDA's senior device official to head AHWP
The Asian Harmonization Working Party has elected as its new chairman the Saudi Food and Drug Authority 's vice president for medical device affairs, ...
TOPRA selects new president
Pfizer's Zubair Hussain has been elected as the new president of The Organisation for Professionals in Regulatory Affairs, a global not-for-profit ...
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