Risk Evaluation and Mitigation Strategies
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 Ph.D. in Pharmacology from the University of Virginia. She is a member of ASQ and AAPS.
Pharmaceutical and biologic products often have adverse effects (AE) that may not be identified until after approval and release. AE 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. AE may be related to class and structure. These events may also occur due to interactions with other pharmaceutical compounds the patient may be taking for the same disease or for another disease. 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. New chemical entities need a risk assessment that can be based on chemical structure or pathways involved in therapeutic effects. Known AE for similar structures, or lack thereof, can be the initial baseline when determining the level of risk. To assure public safety, the FDA requires risk evaluation and implementation of a plan designed to mitigate the risk. These plans are developed as part of a risk evaluation and mitigation strategy (REMS). REMS is designed to inform medical providers and patients of possible AE and guide the required steps when an event occurs. Implementation of a REMS will also help mitigate possible AE by providing steps useful for monitoring patient responses. In addition to monitoring of patients with laboratory testing for critical organ functions, REMS may also provide details for the training of both the patient and the medical provider on early identification of AE. Detailed evaluation of the risks, careful development of an action plan, and proper training of all involved with patient care, including family members and the patient, will lead to an effective REMS designed to meet patient safety expectations.
Adverse events (AE) are a significant issue for many pharmaceutical or
biologic drugs. Developing a plan of action to identify patients at risk
and decrease AE is important. Risk evaluation and mitigation strategies
are designed to educate providers and patients about associated risks
and inform providers and patients of procedures to follow to prevent
serious harm to the patient.
- 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
Course Level - Basic/Fundamental
Who Should Attend
- Pharmaceutical regulatory affairs
- Biopharmaceutical regulatory affairs
- Long-term care facilities
Why Should Attend
Adverse effects may not be identified prior to the release of pharmaceutical or biologic drugs. These untoward events create a risk for the patient population as well as for the drug owner. Serious AE can lead to FDA recalls. 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 the development and implementation of a REMS.
Assessing the risk associated with new pharmaceutical entities or biologic compounds requires a detailed understanding of pathways involved in the therapeutic effect as well as the potential for interference with physiological processes for which the compound may have an impact. Determining suitable monitoring strategies through testing and assessment of specific patient responses offers a mechanism for the collection of data that can lead to advance warning of a potential AE.
Those working in patient care settings, patient monitoring, dispensing of pharmaceuticals or biologics, at-home care, and patient support service should consider attending this webinar to either become familiar with REMS, refresh knowledge, or receive updated information on the implementation of REMS. Attendees will receive knowledge on important and essential requirements related to REMS for potential pharmaceutical adverse effects. This webinar will provide a basic understanding of the requirements for REMS and steps to consider for implementation.