FLH's Brian Malkin to Speak at ExL Pharma Summit on Risk Evaluation and Mitigation Strategies Summit in Alexandria, Virginia
On January 28, 2014, FLH Partner Brian J. Malkin will speak on a panel "Understand the FDA Report [Risk Evaluation and Mitigation Strategies ("REMS") Standardization] and the Impact on the Industry" at ExL Pharma's 6th Risk Evaluation and Mitigation Strategies Summit held on January 28-29, 2014 in Alexandria, Virginia. Joining Mr. Malkin in the panel will be Yola Moride, Ph.D., FISP, Professor, Université de Montréal to help provide an international perspective of this Report with planned topics to include:
- Outlining of the FDA's findings since the public meeting in July 2013
- Explore the implications and impact on the industry
- Outlook on developments in 2014
- Assess changes to the existing regulations
- Understand the real lifecycle of a REMS and the different decision points for modification
- Trends in the conversation of the different regulatory bodies.
The Summit will build upon recent REMS events including the recent Health and Human Services Office of Inspector General Evaluation Report ("OIG"), coupled with the OIG Semi-annual Report to Congress (March 2013), FDA's recent Public Meeting on REMS Standardization and the public docket for FDA's eagerly-anticipated REMS Standardization Initiative Report. While the OIG reports appear to indicate that FDA lacks comprehensive data to determine whether REMS improve drug safety, FDA continues to require REMS in some instances following a drastic reduction in the number of drug products with a REMS. Together, this provides an opportunity and a choice for industry officials to either: more proactively engage and partner with FDA in designing and evaluating such programs or accept the status quo.
Part of the key goals of the 6th Risk Evaluation and Mitigation Strategies Summit is to collect the most experienced professionals from a cross section of small to large companies, pharmacy organizations, hospitals, academia and government agencies share their perspectives, experiences, and leverage the discussions from the FDA public meeting in July 2013. The Summit then provides a well-rounded platform to take a proactive approach and discuss:
- Recent developments and initiatives
- Possible frameworks for standardization
- Tools for evaluation
- Best practices for modification
- Methods to measure the burden
- Lessons learned from various REMS programs
- Innovative approaches to improve REMS effectiveness
- What can be learned from other industries
- Challenges working in single shared REMS.