FLH Partner Brian J. Malkin Speaks on Shared REMS at Q1 Productions' Risk Management Conference in Alexandria, VA
On July 11, FLH Partner Brian J. Malkin will speak at Q1 Productions' Global Clinical Risk Management & Regulatory Policy Conference in Alexandria, VA on the topic "Developing a Single, Shared REMS in a Collaborative Setting". Joining Mr. Malkin will be Mark A. Collings, Ph.D., M.B.A., Director, REMS Programs, Pharmacovigilance and Risk Management, Endo Pharmaceuticals, Inc. The session description reads:
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
- Establishing similar regulatory policies
- Utilizing data from all companies for international RMP development.
The Conference will be held on July 11-12, 2013. Throughout this two-day program, executive from industry will have an opportunity to discuss and debate the many challenges associated with profiling the risk of products as well as minimizing these risks and meeting regulatory expectations. As with all Q1 programs, the focus of the event will not only lie upon the educational content, but also providing attendees with an opportunity to network and build relationships across this highly dynamic and evolving market.