On January 28-29, 2014, ExL Pharma hosted its 6th Annual Risk Evaluation and Mitigation Strategies (“REMS”) Summit in Alexandria, Virginia. For the first time since the Summit has been held, key members from the FDA’s Division of Risk Management attended. In particular, Claudia Manzo, Director, FDA Division of Risk Management, spoke in the main opening panel along with FLH Partner Brian J. Malkin and Yola Moride, Ph.D., FISP, Professor, Université de Montréal. The opening panel featured a discussion of some key take aways from FDA’s Public Meeting on Standardizing and Evaluating REMS in July 2013 and follow-up meeting in December 2013 to identify and discuss new methods for communicating risk information as part of REMS to health care providers and its target populations. The Summit also featured a pre-conference workshop on regulatory negotiation and internal and external audits for REMS, as well as a concluding roundtable session, which focused on some of the key topics raised. The Summit was closed to the media to help encourage a free exchange of ideas.
As promised, the Summit built upon recent REMS events and discussions featuring the most experienced professionals from a cross section of small to large companies, pharmacy organizations, hospitals, academia and government agencies to share their perspectives, experiences, and leverage the discussions in a well-rounded and interactive platform to take a proactive approach covering:
- 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.
Tempered by thoughtful observational comments provided by the Summit’s Chairperson, Mibhor D’Silva, Vice President Safety and Pharmacovigilance, Astellas, and insight from the various keyholders, Summit participants were not only challenged to provide their opinions but also their insight for improving REMS going forward. While many of the discussions focused on the impact of REMS on healthcare settings or health care providers, the goal of REMS to provide better patient risk information and treatment outcomes was also emphasized. Many of the participants commented that they learned much from each other, in particular the logistics of REMS implementation in health care settings, where updates are a constant challenge.
If you have any comments or ideas to share or are interested in speaking at the 7th REMS Summit in 2015 please contact Kai Hahn, Senior Conference Director, firstname.lastname@example.org.