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.

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