Risk Evaluation and Mitigation Strategies (REMS) what you need to know in order to comply with FDA's new requirements

The Food and Drug Administration Amendments Act of 2007 became effective on March 25, 2008. The new law represents a significant addition to FDA authority. Risk evaluation and mitigation strategies (REMS) is the method by which FDA will balance expedited approval of beneficial new drugs against potential serious adverse events that may occur once products are distributed across a wide market. REMS can range from periodic assessment of a product’s post-marketing safety profile to strict limitations on prescribing. Some industry experts predict that every approved product will have some component of REMS. For some products, the package insert is not enough to ensure important safety information gets noticed. Regulatory authorities such as the U.S. Food and Drug Administration are beginning to request additional methods are employed to educate stakeholders about potential risks.

What Attendees will Learn

• What is a REMS(Risk evaluation and mitigation strategies)?
• What products are currently required to have a REMS(Risk evaluation and mitigation strategies)?
• Where to start when writing a REMS(Risk evaluation and mitigation strategies)?
• What department need to be involved in the preparation of a REMS(Risk evaluation and mitigation strategies)?
• Without a REMS(Risk evaluation and mitigation strategies) guidance document ...What format is FDA currently requiiring,?

Who Will Benefit:
This webinar will be valuable to those individuals involved in the development of REMS(Risk evaluation and mitigation strategies) and who are planning a submission and need to understand what might be required by FDA and how to comply and for those who have Risk Management Plans. The biopharmaceutical professionals who will benefit include members from the following departments:

• Regulatory Affairs
• Clinical Research
• Safety and Medical Affairs
• Marketing and Sales

Instructor Profile:
R. Wayne Frost, Pharm.D., JD is the President of Frost Biopharmaceutical Consulting, a consulting firm focused on assisting companies in bringing their drug products to market. We provide services in the areas of overall drug development, regulatory strategy/liaison, clinical development, regulatory affairs submissions including IND’s NDA’s and REMS, DDMAC, labeling and regulatory compliance. Dr Frost has over 20 years experience in the industry having held positions in Pharmacokinetics, Professional Services/Medical Affairs, Clinical Research, Regulatory Affairs and Quality Assurance/Compliance. He has worked for large Pharma and Biotech as well as small biotechnology companies and is experienced in all aspects of drug development. He has gained approvals for new products in many therapeutic areas in US, Canada, and EU.