This webinar on Risk Evaluation and Mitigation Strategy (REMS) will help you understand how to adhere to REMS policy, its implementation and submission requirements. It will discuss FDA's current thinking on REMS, how it reduces the REMS obligations for sponsors, and how the agency's requirements and procedures in this area are evolving.

Why Should You Attend:

Risk Evaluation and Mitigation Strategy (REMS) continues to be a critical part of the FDA’s focussed efforts to increase safety of marketed products (drug or biological). As such they are enforceable by civil monetary penalties of up to $250,000 per violation that can continue to double for subsequent 30-day periods, up to $1 million per period, $10 million per proceeding. Products in violation of REMS requirements may not (continue to) be introduced into interstate commerce.

Learning Objectives:

• When are REMS required?
• What elements need to be included in the REMS?
• What format should be used for submissions?
• How far have some of these requirements been relaxed?

Areas Covered in the Seminar:

• What content must you provide in a proposed Risk Evaluation and Mitigation Strategy (REMS) and what is the format required for a submission?
• What should you include in proposed modifications of an approved REMS?
• What identifiers should you use on REMS documents?
• How should you communicate with FDA about a REMS?
• What do you need to do to update drug safety information?

For Registration:

http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=702316?channel=Eventbrite