Implementation of Risk Evaluation and Mitigation Strategy (REMS) - What do you need to do now?
Duration: 60 Minutes
Attendees will receive knowledge on important and essential requirements related to Risk Management for potential pharmaceutical adverse effects. This webinar will provide basic understanding of requirements for REMS and steps to consider for implementation.
Objectives of the Presentation
Why Should you Attend
- Risk Management and Risk Minimization Action Plans 2005
- Consequences of FDAAA 2007
- Understanding the impact
- Assessing the potential need for a REMS
- Responding to a requirement for a REMS
- Voluntary submission of a REMS
- Implementing a REMS
Pharmaceutical and biologic products may have adverse effects. This can be observed either in general or in specific patient populations. Adverse effects may be related to class and structure and may be observed after approval of the drug. Strategies must be in place if a pharmaceutical or biologic product is deemed to likely have or is observed to exhibit a harmful response in addition to the health benefit. To assure public safety, the FDA requires implementation of a plan designed to mitigate the risk. These plans are developed as part of a risk evaluation and mitigation strategy (REMS).
Who will Benefit
- FDAAA and risk management
- Assessing the need for REMS
- REMS and adverse effects
- Contributing factors
- Preparing a REMS
- Submission timeline
- Patient registration
- Regulatory Affairs
- Clinical Research Administrators
- Study Sponsors
- Senior Management (production, supply chain and operations)
- Medical Affairs
- Clinical Development
- Clinical Affairs
- Clinical Research
Pharmaceutical and biologic products often have untoward effects in patient populations. The FDA requires that a plan be in place (Risk Evaluation and Mitigation Strategy or REMS) to assure continued safety of a drug. The purpose of these plans is to provide information to providers, pharmacies, and patients about the risks associated with certain drugs deemed to need REMS. Effective REMS addresses all potential issues, communicates the plan, has good implementation, and has follow-up to assess the impact of the plan.