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.
Proper adherence to REMS regulations is critical. However, the implementation of a REMS can be challenging. It must be undertaken by a specified protocol, departure from which requires agreement with the FDA. This webinar will explain the above. Participants will understand when a REMS will be required, the elements that need to be included in the REMs needed for their product, as well as details of the two-part format required for submission: the proposed REMS and the more detailed REMS supporting documents. Also, the FDA requirements and procedures continue to evolve. We will adress the agency's current thinking in some instances and show how they reduce the REMS obligations for sponsors.
- 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?
Added by complianceonlinecom on June 1, 2012