REMS Update: Risk Evaluation and Mitigation Strategies - Webinar By ComplianceOnline

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?
• When do you need to distribute a Medication Guide?
• What are the key points that you need to know about The Medication Guide Regulations?
• When can you take advantage of Shared System REMS?
• What do you need to know about of the March 2012 Draft Guidance on Drug Safety Information?