Third Forum of the Ministerial Industry Strategy Group (MISG) - 3 September 2008

The third Forum set up under the Ministerial Industry Strategy Group (MISG) met on 3 September 2008.  They examined the tools and techniques currently available to enable the pharmaceutical industry and regulators to undertake formalised assessments of the benefits and risks associated with medicines during the lifecycle of the medicine, and what developments were needed to improve on current practice. The Forum also considered how benefit:risk can best be communicated to patients, clinicians and other stakeholders.

The report of the meeting, list of attendees, background documents and presentations given are available below:

› MISG Forum report on benefit:risk decision analysis (204Kb)
- please note that an updated version of this paper has now been published, which takes account of a small number of important changes offered by experts present on the day

› List of attendees (9Kb)

Background Documents

› Quantitative decision analysis: A work in progress (109Kb)

› Making regulatory decisions about medicines and medical devices (44Kb)

› Current assessment of risk–benefit by regulators: Is it time to introduce decision analyses? (169Kb)

› Assessing a structured, quantitative health outcomes approach to drug risk-benefit analysis (140Kb)

› EMEA Reflection paper on benefit-risk assessment methods in the context of the evaluation of marketing authorisation applications of medicinal products for human use (77Kb)

› Benefit-risk assessment model for medicines: Developing a structured approach to decision making (611Kb)

› Measuring benefit and balancing risk: Strategies for the benefit-risk assessment of new medicines in a risk-averse environment - Workshop report (365Kb)

MISG Forum presentations - 3 September 2008

› MISG - Benefit-risk decision taking - Ian Hudson (897Kb)

› MISG - Forum on benefit-risk decision analysis - Joyce Korvick (385Kb)

› MISG - What patients expect to be taken into account in the risk-benefit decision - Jayne Spink (261Kb)

› MISG - Techniques for improving benefit-risk assessment - Adrian Towse (1690Kb)

› MISG - Multi-criteria decision analysis for appraising benefit-risk - Professor Lawrence Phillips (1468Kb)

› MISG - Benefit: Risk decision-making for individuals and drug regulators - Professor Deborah Ashby and Rob Hemmings (1413Kb)

› MISG - Benefit/risk assessment of medicines – Research needs and future directions - Professor Stuart Walker (252Kb)