Regulatory review: How do agencies ensure the quality of the decision?
The role of decision frameworks in the review of new medicines: What are the challenges and solutions that can facilitate agencies to make quality decisions?
24-25 January 2013, Beijing, China
The science of decision making is well established and a number of common features have been identified that characterise good- quality decisions such as a good decision framework; creative doable options; meaningful, reliable information; clear values and tradeoffs; logically correct reasoning; and a commitment to action. However, methods for building these qualities into the regulatory decision process remain to be elucidated. Moreover, although international work is being undertaken to ensure that there is an acceptable and established framework for the benefit-risk component of decision processes, the challenges within agencies to ensure that quality decisions are being made across all aspects of the dossier review remain to be addressed. It is, therefore, important that the decision processes within an agency — from the processes used by the individual reviewer through to the final decision maker — are well understood and characterised.
Workshop objectives
- Identify the different decision-making frameworks used by sponsors and agencies
- Understand the challenges for organisations in making quality decisions
- Discuss and make recommendations for activities and processes that sponsors and agencies can consider to enable quality decision making.