Risk Evaluation and Mitigation Strategies - Webinar By ComplianceOnline
Thursday, June 14, 2012 from 10:00 AM to 11:00 AM (PDT)
Palo Alto, CA
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.
- 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 & Where
At ComplianceOnline, we are focused on :
- Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
- Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
- Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
- Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.