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 analysisPDF file (opens in new window) (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 attendeesPDF file (opens in new window) (9Kb)

Background Documents

Quantitative decision analysis: A work in progressPDF file (opens in new window) (109Kb)

Making regulatory decisions about medicines and medical devicesPDF file (opens in new window) (44Kb)

Current assessment of risk–benefit by regulators: Is it time to introduce decision analyses?PDF file (opens in new window) (169Kb)

Assessing a structured, quantitative health outcomes approach to drug risk-benefit analysisPDF file (opens in new window) (140Kb)

EMEA Reflection paper on benefit-risk assessment methods in the context of the evaluation of marketing authorisation applications of medicinal products for human usePDF file (opens in new window) (77Kb)

Benefit-risk assessment model for medicines: Developing a structured approach to decision makingPDF file (opens in new window) (611Kb)

Measuring benefit and balancing risk: Strategies for the benefit-risk assessment of new medicines in a risk-averse environment - Workshop reportPDF file (opens in new window) (365Kb)

MISG Forum presentations - 3 September 2008

 MISG - Benefit-risk decision taking - Ian HudsonPDF file (opens in new window) (897Kb)

MISG - Forum on benefit-risk decision analysis - Joyce KorvickPDF file (opens in new window) (385Kb)

MISG - What patients expect to be taken into account in the risk-benefit decision - Jayne SpinkPDF file (opens in new window) (261Kb)

MISG - Techniques for improving benefit-risk assessment - Adrian TowsePDF file (opens in new window) (1690Kb)

MISG - Multi-criteria decision analysis for appraising benefit-risk - Professor Lawrence PhillipsPDF file (opens in new window) (1468Kb)

MISG - Benefit: Risk decision-making for individuals and drug regulators - Professor Deborah Ashby and Rob HemmingsPDF file (opens in new window) (1413Kb)

MISG - Benefit/risk assessment of medicines – Research needs and future directions - Professor Stuart WalkerPDF file (opens in new window) (252Kb)

Page last modified: 15 December 2009