This book compiles the presentations and syndicate discussions from a CIRS workshop that brought together representatives from international pharmaceutical companiesand regulatory authorities from Europe, US, Canada and Australia and HTA agencies from Europe and Canada along with experts in the science of decision making. The sessions focused on why measuring decision making is important as well as on discussing the outcome of the pilot studies and surveys that CIRS has conducted with these organisations to measure the quality of their decision-making processes. In addition, as the benefit-risk framework is now becoming the cornerstone of building quality into the critical decisions within companies and agencies, there were also presentations on understanding and identifying how the benefit-risk decision framework is being built into the broader decision-making process.
It is hoped that this book will increase the awareness as well as the practices of quality decision making and be of value to all stakeholders involved in the development, regulatory review and the reimbursement of medicines.
Walker S, McAuslane N, Bujar M, Connelly P, Liberti L. Quality decision-making practices: Their application and impact in the development, review and reimbursement of medicines. Amsterdam: Off Page; 2017.