In September of 2009, the FDA issued a draft guidance for industry on the format and content of a proposed risk evaluation and mitigation strategy (REMS), which included REMS assessments and proposed REMS modifications. Many industry experts are working to manage the detailed requirements of this new pharmacovigilence standard to include more and tighter control over drug uses.

This session provides insight into medication guides, patient package inserts, communication plans, timelines and other elements to ensure safe use. Attendees receive helpful tips about the format and contents of REMS submissions, as well as some good practices for execution of REMS strategies.

This audio conference covers:

• What is REMS?
• When is a REMS required?
• How to prepare for a REMS submission
• What is a medication guide?
• An example of a REMS program

About the speaker:

Dr. Joy Frestedt has over 30 years of scientific, clinical and regulatory experience in the health care, pharmaceutical and medical device industries. She has held key positions including vice president of scientific and clinical affairs at BridgePoint Medical and Humanetics Corporation, as well as other positions with Johnson & Johnson, Medtronic, Mayo Clinical Trial Services, AstraZeneca Pharmaceuticals and Orphan Medical.

Dr. Frestedt holds a B.A. in Biology from Knox College and a Ph.D. in Pathobiology from the University of Minnesota Medical School. She is a member of the American Society of Clinical Oncologists, the American Association of Pharmaceutical Scientists, the American Society of Clinical Research Professionals, and currently serves as chair of the Ethics Committee for the Regulatory Affairs Professionals Society.

Who should attend?

• Clinical Development/Operations
• Research & Development
• Health & Safety
• Quality Assurance
• Regulatory Affairs
• Labeling/Packaging
• Documentation Managers
• Marketing & Communications