On July 11-12, Q1 Productions (“Dedicated to Quality First®) will be hosting in Alexandria, Virginia, its Global Clinical Risk Management & Regulatory Policy Program: Implementation of Advanced Risk Management Plans that Increase the Effectiveness of Risk Assessment and Mitigation, while Increasing Drug Safety and Meeting Regulatory Policy & Guidance on a Global Level. FLH Partner Brian J. Malkin is featured to speak on July 11 with the topic: “Developing a Single, Shared REMS in a Collaborative Setting”. The session description for Mr. Malkin’s presentation states:
The FDA approves single, shared REMS for product categories with similar risk management programs to help relieve some of the burden on healthcare providers and pharmacies. The development of shared REMS requires that multiple companies and the FDA work in tandem to unify data and risk minimization systems, a model which some companies have also used to help organize risk management plans internationally. By ensuring a strong cross-corporate collaboration, internal regulatory policies, data analysis and communication systems can be synchronized internationally for advanced risk management programs.
- Structuring lines of communication within shared REMS network