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.
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.
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?
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What do you need to know about of the March 2012 Draft Guidance on Drug Safety Information?
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.
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?
Who Will Benefit:
This webinar will provide valuable assistance to the following personnel in pharmaceutical manufacturing, drug, biologic and clinical research companies:- Regulatory Affairs
- Compliance
- Clinical Research Administrators
- Study Sponsors
- Legal
- Senior Management (production, supply chain and operations)
Course Provider
Orest Hurko,
