Within three years the FDA has requested and approved 161 REMS. More than ninety REMS have been modified or approved in 2010 alone. Of those ninety REMS, thirty six included more elements than just the medication guide. If this year’s rate continued, five years from now, there would be more than 600 approved REMS. If the FDA required you to create a REMS, are you prepared?
Learn more about what this full day virtual conference will offer you!
Led by conference Chair Michael McCaughan, editor of The RPM Report and Founding Member of Prevision Policy LLC, this virtual conference will address the evolution of REMS and key challenges currently facing the industry. Through in-depth case studies you will discover lessons learned by pharmaceutical companies that have worked with the FDA to develop and assess their Risk Evaluation and Mitigating Strategies.
By attending this virtual conference you will learn what requirements you must meet to ensure that your REMS are effective and satisfy FDA expectations. You will also get an exclusive opportunity to hear The RPM Report’s latest, just-published data on the trends in FDA’s use of the new Risk Evaluation & Mitigation Strategies.
During this full day virtual conference, attendees will:
• Review the importance of REMS in the evolution and regulation of pharmaceuticals in the U.S.
• Clarify performance benchmarks and expected results from assessments
• Explore the major challenges in designing and implementing REMS
• Assess the impacts of REMS programs on patients and the delivery of health care
• Describe the mechanisms the Sabril REMS uses to meet the five required elements to assure safe use
• Learn how the REMS was designed and finally implemented at Actelion
Risk Evaluation and Mitigation Strategies Virtual Conference
Wednesday, December 15, 2010 * 10:00 AM EDT - 4:15 PM EDT
REGISTER TODAY!