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pharmaceutical risk management and optimal medication use, will host a free webinar on Wednesday, Dec. 9, on the FDA's draft guidance on REMS - Risk Evaluation Mitigation Strategy - programs and its implications for REMS lifecycle management.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 http://www.paragonrx.com/calendar/78/42-FDA-Draft-REMS-Guidance-Implications-a nd-Opportunities-for-REMS-Lifecycle-Management. ParagonRx has also published a series of articles summarizing the guidance (http://blog.paragonrx.com/).
 

Source: ParagonRx

CONTACT: Roger Morris, The LondonBritain Company for ParagonRx,
+1-610-274-8027, londonbritain@msn.com
 

Web Site: http://www.paragonrx.com/

Posted: December 2009

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