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Regulatory Region - Europe


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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 ...
 
23 February 2012
Amanda Maxwell
The European Diagnostics Manufacturers Association is at a pivotal junction in its history. Among other things, intense discussions over the proposed ...
 
22 May 2012
Matthew Royle and Helen Cline consider the latest legal opinion from the EU on the interpretation of the SPC legislation to be good news for companies investing in research to investigate new formulations and uses of known active ingredients but ...
18 May 2012
Planned change on the choice of reference product for biosimilars in the EU means global development is on the agenda. Maureen Kenny reports from the EGA biosimilars conference in London. The EU is preparing for a major change in biosimilars ...
04 May 2012
Planned change on the choice of reference product for biosimilars in the EU means global development is on the agenda. Maureen Kenny reports from the EGA biosimilars conference in London. The EU is preparing for a major change in biosimilars ...
 
Regulatory Affairs Medtech News Roundup, December 2010
09 December 2010
 
EU pharma excipients industry association gets new secretary general The European chapter of the International Pharmaceutical Excipients Council has appointed Laurent Boll as its new secretary general 1 . Mr Boll's appointment was cleared by IPEC Europe's board on 15 May. A graduate from the University of Maastricht ...
EU qualified persons association recruits new members The European Association of Qualified Persons has nominated two new members to its board. The latest nominees are Ulrich Kissel of Roche (Germany) and Edit Sz?cs from the Hungarian National Institute of Pharmacy (NIP) 1 . Dr Kissel has more than 15 ...
 
   
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