Regulating Medicines in a Globalized World
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 relying 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 recently released study that was funded by the US FDA and coordinated by the National Academies of Sciences, Engineering, and Medicine titled, 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
Who should attend?
Professionals who work in the area of:
- Medicines regulation
At the conclusion of this webinar, participants should be able to:
- Use the information discussed to start a broader conversation with national regulatory bodies about the value and challenges with setting up and maintaining mutual and unidirectional arrangements for regulatory reliance, including but not limited to MRAs
- Be able to apply the input they receive from participants to better target their messaging to future conversations on regulatory reliance
Continuing Education Credits are not available for this event.