Implementation of Risk Evaluation and Mitigation Strategy (REMS) - What do you need to do now?
Duration : 60 Minutes
Gwendolyn Wise-Blackman,
Gwen Wise-Blackman 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), Covance, and Salix Pharmaceuticals. Her focus has been in High-Throughput Screening, Cell-Based Assay Method De Read more
Attendees will receive knowledge on important and essential requirements related to Risk Management for potential pharmaceutical adverse effects. This webinar will provide
Course Objectives:
• 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
Background:
Pharmaceutical and biologic products often have untoward effects in patient populations. The FDA requires that a plan
Why Should You Attend:
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).
Course Outline:
• FDAAA and risk management
• Assessing the need for REMS
• REMS and adverse effects
• Contributing factors
• Preparing a REMS
• Communication
• Submission timeline
• Implementation
• Patient registration
What You Get:
• Training Reference Materials
• Live Q&A with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Regulatory Affairs
• Compliance
• Clinical Research Administrators
• Study Sponsors
• Legal
• Senior Management (production, supply chain
• Pharmacovigilance
• Medical Affairs
• Clinical Development
• Clinical Affairs
• Clinical Research
• Pharmacists
• Biostatisticians
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
