Since their inception more than a decade ago, Risk Evaluation and Mitigation Strategy (REMS) programs have evolved in both scope and complexity, in many cases creating undue burdens on patients, pharmacists and manufacturers. The challenge has been -- and continues to be: How can REMS programs adequately mitigate risk and minimize stakeholder burden? A large and, we suggest, necessary part of the answer lies with cooperation and communication between manufacturers, REMS service providers and the FDA.
REMS best practices and the importance of cooperation and communication between manufacturers and the FDA were some of the subjects of the 4th Annual REMS Leadership Summit for pharmaceutical industry executives, sponsored by Syneos Health. Participants also discussed REMS trends, standardization efforts, technologies, FDA guidance and other topics. Download our new white paper to learn more.
