Webinar to Explore FDA Draft REMS Guidance and Its Implications for Lifecycle Management
WILMINGTON, Del., Dec. 3 /PRNewswire/ -- ParagonRx, a
Delaware-based company specializing in pharmaceutical risk
management and optimal medication use, will host a free webinar on
Wednesday, Dec. 9, on the FDA's draft guidance on REMS - Risk
Evaluation Mitigation Strategy - programs and its implications for
REMS lifecycle management. Dr. Gary Slatko, chief medical officer
of ParagonRx and an expert on REMS and risk management programs,
will lead the one-hour program beginning at 11 a.m. EST.
"While much within the guidance was anticipated, there were some
aspects that were both unexpected and represent exciting
opportunities for our industry," Dr. Slatko said. "These include
new options, such as implementing voluntary risk mitigation
measures beyond a REMS, modifying the assessment timetable and
modifying the REMS program and/or its goals. Other aspects were
incompletely addressed, such as evidence-based risk assessment and
patient tools beyond Medication Guides."
Anyone interested in the topic may participate by registering at
nd-Opportunities-for-REMS-Lifecycle-Management. ParagonRx has also
published a series of articles summarizing the guidance (http://blog.paragonrx.com/).
CONTACT: Roger Morris, The LondonBritain Company for
Web Site: http://www.paragonrx.com/
Posted: December 2009