Background The science of decision making is well established, although in reality it is a mixture of science and art. What is currently lacking is research into decision making [...]
Introduction: The impact of decision-making during the development and the regulatory review of medicines greatly influences the delivery of new medicinal products. Currently, there is no generic instrument that can [...]
Exploring approaches to decision making 11-12 June 2015, Washington DC, USA This workshop focused on identifying the other factors and influences that companies and agencies need to consider to [...]
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 [...]
An efficient review depends not only on timely approval but also on ensuring the quality of the process from construction of the dossier to the ultimate regulatory decision. Two [...]
Regional alignment in Asia Pacific: What needs to be in the regulatory science toolkit to enable good regulatory decision making? 26-27th January 2011, Tokyo, Japan Regulatory agencies are rising [...]
Quality decision making: Procedures and practices in drug development and the regulatory review 7-8th December 2006, Surrey, UK Benefit and risk for patients, the success or failure of companies’ [...]
The Institute for Regulatory Science is currently involved in several activities related to quality as it applies to regulatory submissions and procedures, rather than the more conventional association with [...]
Building quality into regulatory dossiers and the review process: Knowing and meeting customer expectations 2nd-3rd December 2004, Woodlands Park Hotel, Surrey, UK Overview This was the fourth Workshop organised [...]