Are the risk mitigation measures within a REMS (Risk Evaluation and Mitigation Strategy) adequate enough to ensure optimal benefit-risk management? Even if the FDA doesn’t require a REMS for a product, does it make sense to undertake risk management measures anyway? (more…)
Archive for the ‘Webinar’ Category
Complimentary Webinar to Address: Is a ‘Voluntary REMS’ a Good Risk?
Monday, April 11th, 2011ParagonRx Webinar to Provide Guidance On FDA Draft Guidance for MedGuides in REMS
Friday, March 4th, 2011A complimentary webinar will be presented by ParagonRx on the implications and ramifications of the newly released FDA draft guidance, Medication Guides — Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS).
“Our ‘Guidance’ on the FDA Draft Guidance for MedGuides in REMS” will be the focus of a free webinar which will take place Wednesday, March 9, at 12 noon Eastern Time. The topic is the latest in a series of monthly “Wednesday FoREMS” webinars sponsored by ParagonRx, an inVentiv Health company, pioneering expertise in REMS and Benefit-Risk Management. (more…)
REMS 2010: A Year in Review
Friday, December 3rd, 2010As the pharmaceutical community looks forward to the issuance of the new FDA Risk Evaluation & Mitigation Strategies (REMS) guidance in 2011, a free webinar will examine all the REMS occurrences during the past year and what they will portend for the future. (more…)
