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The Business of Pharmacovigilance: Understanding REMS During a Public Health Emergency
How should you handle your risk evaluation and mitigation strategy (REMS) programs in the age of COVID-19? The FDA just issued guidance for these unprecedented times that will remain in effect until the end of the public health emergency.
Its “Policy for Certain REMS Requirements During the COVID-19 Public Health Emergency” — issued without a comment period — states providers should consider whether there are “compelling reasons not to complete these tests or studies” during the pandemic.
During the pandemic, you may find it difficult to finish REMS-required lab tests or imaging studies as patients self-isolate or are quarantined. The FDA itself stated, “Under these circumstances, undergoing laboratory testing or imaging studies in order to obtain a drug subject to a REMS can put patients and others at risk for transmission of the coronavirus.”
Given that there are no other current standards or guidelines for reducing the burden of these programs at the pharmaceutical manufacturing level, how should you proceed for the ultimate success of your REMS program?
Catherine Baldridge, MS, owner/founder of Essential Pharmacovigilance, LLC, will discuss REMS critical components, explain the importance of advanced planning and proper resource allocation to prepare you for the ultimate success of your REMS programs during this public health emergency.
An emphasis will be placed on the importance of advanced planning for a REMS program, as well as the tools to have in place and the topics to discuss when bringing on a contract research organization (CRO) partner and/or developing an in-house program.
Presentation Takeaways:
- Which specific elements to assure safe use (ETASU) in your REMS program
- The recommended lead time for preparing for a REMS program in order to provide adequate scheduling for companies and CROs
- The recommended quality and compliance processes you need to consider during an implementation, including audit recommendations and legal considerations
- The importance and value of cross-functional engagement when developing and implementing a program, such as collaboration with your commercial and supply teams
- What the impact of the program on the global pharmacovigilance (PV) system is, including financial impact, and relevance to the qualified person responsible for pharmacovigilance (QPPV) and risk management plan (RMP) programs
- State-of-the-art operational PV tactics (tools, SOPs, training) you must know for implementing and managing a program
This is the first time this topic is being addressed from an industry perspective — and the FDA’s guidance is in effect until the COVID-19 public health emergency is over. If you’re planning for a REMS this opportunity is critical.
Meet Your Presenter:
Catherine Baldridge, MS, Owner/Founder of Essential Pharmacovigilance, LLC, is an executive consultant focusing on Clinical Safety and Pharmacovigilance. She has over 16 years of pre- and postmarket product safety lifecycle development, research and surveillance experience. Ms. Baldridge holds a Masters of Science in Clinical Research, Health Evaluation Sciences from the University of Virginia, and a Bachelors degree in Psychology, with dual concentrations in Neuro and Clinical, from Hollins University. In addition to consulting, she currently serves as Adjunct Faculty at Temple University, School of Pharmacy, in their Regulatory Affairs and Quality Assurance Graduate Program teaching courses in Good Pharmacovigilance Operations and Clinical Safety and Pharmacovigilance.
Who Will Benefit:
- Chief Medical Officers
- Chief Executive Officers and/or CFOs
- Executive Pharmacovigilance Personnel (Heads of Safety/PV)
- Heads of Regulatory Affairs
- Quality Assurance Personnel (Heads)
- Legal Affairs Personnel
- Supply Chain Management/Commercial Operations Personnel
- Marketing and Communications Personnel
- Research & Development Personnel