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Audio conference highlights

One of the provisions of the Food and Drug Administration Amendments Act of 2007 (FDAAA) is that the FDA requires manufacturers to submit a Risk Evaluation and Mitigation Strategy (REMS) when a drug or biologic first comes on the market, or later if they become aware of new safety data about the drug. What risk signals should be looked for early in the development process?

In this audio conference we present case studies of various levels of REMS requirements and focus on how to use post-market surveillance requirements to support your product safety profile. Meeting the challenges raised by FDAAA through optimal risk management and utilizing integrated activities that begin with early clinical testing are key, and must continue throughout the product lifecycle.

This audio conference covers:

• Optimizing the "Elements to Ensure Safe Use"
• How assessments of REMS are critical to successful program development
• Why the FDA REMS authority can be good for the industry
• Rationale for FDA to require a REMS for existing drugs via new safety information

About the speakers:

Dr. Edgar Adams is Executive Director, Epidemiology, at Covance Periapproval Services. He is responsible for providing scientific and technical leadership in epidemiology, biometrics, and risk management. He has more than 15 years of experience consulting on the design, assessment and implementation of risk minimization action plans (RiskMAPs), postmarketing surveillance, and drug scheduling nationally and internationally. Dr. Adams was a Commissioned Officer in the U.S. Public Health Service, and has served as the Chief Epidemiologist at the National Institute on Drug Abuse (NIDA), where he was responsible for the Nation's Drug Abuse Surveillance effort, including the National Household Survey on Drug Abuse, and the Drug Abuse Warning Network (DAWN).

Robin Carter is a Senior Director of Operations, Risk Management, at Covance Periapproval Services. She is responsible for the overall operational project plan, implementation strategy, resources, budget and quality of risk management programs. In her former role at Covance, Robin was an original member of the iPLEDGE Program launch team, serving as the Account Director for the iPLEDGE Contact and Triage Center. Prior to joining Covance in 2006, Robin was the Vice President of Cystic Fibrosis Services, Inc. (CFS), a nationwide specialty pharmacy with three locations across the U.S servicing the needs of patients with cystic fibrosis. She has also been an instrumental partner with pharmaceutical manufactures for the commercial launch of several biotech medications.

Who should attend?

• Vice Presidents
• Directors
• Managers
• Project Coordinators and Associates

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