Risk Evaluation and Mitigation Strategies
Date : 12 December 2018
Time : 02 : 00 PM EST
Duration : 60 Minutes
Gwen Wise-Blackman, Ph.D. has 20 years of combined experience in Cell-Based Assays and Quality Systems. She has worked at DuPont Pharmaceuticals, Catalent Pharma Solutions (formerly Magellan Laboratories and Cardinal Health), and Salix Pharmaceuticals where she successfully managed multiple projects and held positions of increasing accountability for scientific and quality expertise. Currently she is the owner of Gwen Wise-Blackman Consulting, LLC, a biopharmaceutical consulting firm. Her focus has been in High-Throughput Screening, Cell-Based Assay Method Development and Validation, Ligand Binding Methods, Technology Transfer, GxP Regulations, and Quality Assurance. Dr. Wise-Blackman has a Bachelor of Science degree in biology from M.I.T and a PhD in Pharmacology from the University of Virginia. She is a member of ASQ and AAPS.
Adverse effects may not be identified prior to release of pharmaceutical or biologic drugs. These untoward events create a risk for the patient population as well as for the drug owner. Having a Risk Evaluation and Mitigation Strategy (REMS) is an essential component of product release that should be understood and incorporated in release plans. This webinar addresses issues surrounding REMS. 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.
Pharmaceutical and biologic products may have adverse effects. This can be observed either in general or in specific patient populations whether the patient is at home or in a hospital or other care facility. 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).
- 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
- Setting Timelines
- Patient Registry
Who Should Attend
- Pharmaceutical regulatory affairs
- Bio-pharmaceutical regulatory affairs
- Long-term care facilities
- Speaker: GWENDOLYN M. WISE BLACKMAN
- Webinar Code: GWEN-0004