In this webinar...
In an environment of limited human and financial resources and at a time of unprecedented globalization and societal requests for faster approvals of drugs, medicines regulators have felt the pressure to stretch their finite resources. To address this regulatory challenge, regulatory authorities have set up various arrangements to rely on each other’s work—the most formal (and costly) of which are mutual recognition agreements (MRAs). However, regulatory authorities with the same challenges, but significantly more limited resources, have set up other arrangements that take a unidirectional approach to rely on the work products of others. The purpose of this webinar is to explore both approaches—mutual and unidirectional reliance—to better understand the challenges and opportunities of the various types of arrangements within these two forms of reliance.
- Review the recently released study that was funded by the FDA and coordinated by the National Academies of Sciences, Engineering, and Medicine, Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators
- Get feedback on the messages from the participants regarding bi-directional regulatory reliance arrangements and uni-directional arrangements
- Alastair Wood, MB, ChB, FRCP, FACP, Emeritus Professor of Medicine and Emeritus Professor of Pharmacology, Vanderbilt University Medical School
- Lembit Rägo, MD, PhD, Secretary-General, Council for International Organizations of Medical Sciences