We invite you to listen to the PRA Risk Management, Epidemiology and Late Phase Operational experts who are currently consulting, designing and conducting REMS activities under the new FDAAA regulations. These experts give insight into current issues concerning REMS, such as risk management activities, observational safety-surveillance studies and performance-linked access programs. They also discuss the potential payoff from the new REMS requirements, as well as which REMS requirements have been proposed for incorporating adaptive designs.

In this audio conference the speakers present various REMS strategies based on a “tiered” approach, as well as some recent case studies. In addition, the presenters cover lessons learned and program components to consider, based on current FDA thinking and requirements for a REMS.

This audio conference covers:

• Current requirements under FDAAA 2008 (FD&C Act)
• Overall approach to REMS design, execution and reducing stakeholder burden
• Matching REMS program components to risk mitigation and operational strategy
• Lessons learned involving stakeholders in design
• Added value provided by a REMS

About the speakers:

Mark Nelson Tyrrell has over 15 years of experience in pharmacovigilance in both pharma and the CRO industry. His focus for the past five years has been in the design, implementation and ongoing evaluation of Phase-IV studies, registries and observational studies, and RiskMAP/REMS development. Mark's therapeutic experience is extensive, having provided cognitive pharmacy services to patients in the areas of psychiatry, infections disease, heart failure, diabetes and neurology, as well as directing treatment programs in pain management, clozapine and warfarin.

Kathleen Kushner is responsible for providing consulting services and developing postmarketing operational strategies for marketed products. Her experience includes strategic design and implementation of late phase studies, where she directed all operational aspects including clinical operations, data management, pharmacovigilance, biometrics and external vendors (including claims databases). She has managed several programs ranging in size from 60 to 18,000 patients in a number of countries (US, Canada, Europe, Central/South America, and Asia) and in many therapeutic areas (CNS, dermatology, GI, ophthalmology, men’s health and oncology).

Dr. Jerome Wilson is responsible for providing consulting services and developing postmarketing scientific strategies for marketed products. He has more than 15 years of scientific management experience in the pharmaceutical industry and has worked with the Office of the Assistant Secretary Preparedness and Response at the U.S. Department of Health and Human Services (HHS) in Washington, DC, and served as Associate Director for Scientific Program Operations at the National Center on Minority Health and Health Disparities at the NIH. Dr. Wilson has also received the NIH Director’s Award for his work on the Genome Wide Association Studies Policy Development Team.

Who should attend?

• Directors/Managers of Drug Safety & Pharmacovigilance
• Directors/Managers of Regulatory Affairs
• Directors of Benefit/Risk Management
• Directors/Managers of Clinical Operations
• Medical Directors

*Please note: Each registration covers one line connected to the audio conference. Attendees dialing from separate locations are required to have separate registrations.