Legislation
News
FDA and EMA accept single orphan drug annual report – 1-Mar-2010
US and Europe in co-operative move to speed annual reports
Ablynx wins patent opposition case against Domantis – 12-Feb-2010
Ablynx, a Belgian developer of nanobodies, has been successful its patent opposition case against Domantis, now part of GlaxoSmithKline.
Brothers fined for illegal supply of drugs – 12-Feb-2010
Two brothers have been fined for illegally selling a sexual dysfunction drug from their home via a number of websites.
European inspectors set out their work plan for 2010 – 3-Feb-2010
EMA news in brief – 3-Feb-2010
The EMA has released a concept paper on developing guidelines in using risk-based approaches when assessing advanced therapy medicinal products
Technical
Voluntary procedure on trial – 5-Feb-2010
Is the Voluntary Harmonisation Procedure the way forward for multinational clinical trials in the EU? Hilary Ayshford reports from the recent TOPRA/EMA meeting on how things are progressing
Children on board – 24-Jan-2008
Now that the new Paediatric Regulation has arrived, Dr Robert Harris, head of formulation development at Penn Pharmaceutical Services highlights its implications for drug developers
Keep an eye on the future – 31-Jul-2003
Pharmaceutical companies should 'future-proof' inspection solutions now rather than be caught out by EU Legislation, warns Alan Johnson of Loma Systems
The healthy option? – 18-Sep-2002
Are nutraceuticals food or pharmacy? That is a question that EU and US regulators are grappling with Nick Hawker, from Vitafoods International, discusses the issues involved
Events
Regulatory Intelligence – 8-Mar-2010
19 March, 2010
San Diego, CA, US
Drug Approval Process – 24-Feb-2010
16 - 17 March
San Diego, California, US
Mastering Clinical Trial Monitoring – 22-Feb-2010
24 - 25 June 2010
Royal Sonesta Hotel, Cambridge, Massachusetts, US
5th Annual Pharmacovigilance Conference – 22-Feb-2010
17 - 19 March 2010
BSG House, London, UK
An Introduction to the Medical Device Directives – 15-Feb-2010
6 - 7 May 2010
The Rembrandt Hotel, London, UK
Medical Device Clinical Investigations and Evaluations – 15-Feb-2010
15 - 16 March 2010
The Rembrandt Hotel, London, UK
Adverse Events: Managing and Reporting for Pharmaceuticals – 11-Feb-2010
23-24 March 2010
Philadelphia, Pennsylvania, US