Benefit-risk assessment: industry and regulatory perspectives

In 1998, the Council for International Organizations of Medical Sciences (CIOMS), Working Group IV published guidelines entitled Benefit-Risk Balance for Marketed Drugs: Evaluating Safety Signals. At a recent meeting jointly organised by Management Forum and the UK Medicines Control Agency (MCA), entitled 'Risk Benefit Assessment' [London, UK; November 2001], the practical applications of these guidelines were discussed by representatives from both industry and regulatory authorities.