Highlights of the CMR International institute Workshop on Risk Management: The role of regulatory strategies in the development of new medicines, Washington DC, 12-13 December 2002

Following a number of high profile product withdrawals, risk management has an increased priority for the pharmaceutical industry. Whilst the concept of risk management for medicines has been under discussion for many years, few companies have yet built specific risk management strategies into their drug development programmes. Similarly, benefit/risk assessment is becoming an increasingly important factor in the drug approval process, but regulatory authorities have yet to develop clear guidance on the parameters for such assessments.

Against this background the Centre for Medicines Research (CMR) International’s Institute for Regulatory Science held two workshops in 2002 at which participants from senior management in industry and regulatory agencies explored the need to develop a clearer framework for risk management throughout the life cycle of a medicine. The first workshop, held in the UK in April 2002 focused on regulatory strategies and models for benefit/risk assessments. One of the main recommendation was that industry and health authorities together should look more closely at their current communication strategies and assess where improvements could be made to meet the requirements of all stakeholders. The Institute therefore convened a second Workshop to look specifically at ‘Stakeholder Communications during Drug Development’ in order to implement best practices for the benefit of all parties. The highlights of the second Workshop, which took place in Washington DC, 12-13 December 2002, are summarised in this briefing.