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.
Risk Evaluation and Mitigation Strategy
Product ID: 507343
Objectives of the Presentation
  • 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
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).

Areas Covered
  • FDAAA and risk management
  • Assessing the need for REMS
  • REMS and adverse effects
  • Contributing factors
  • Preparing a REMS
  • Communication
  • Submission timeline
  • Implementation
  • Patient registration
Who will Benefit
  • Regulatory Affairs
  • Compliance
  • Clinical Research Administrators
  • Study Sponsors
  • Legal
  • Senior Management (production, supply chain and operations)
  • Pharmacovigilance
  • Medical Affairs
  • Clinical Development
  • Clinical Affairs
  • Clinical Research
  • Pharmacists
  • Biostatisticians
Topic Background
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.
$375
Recorded Session for one participant
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Live Session - How it works
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  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
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  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Gwendolyn Wise-Blackman is a successful scientist/manager with increasing accountability for scientific expertise and budget in the pharmaceutical industry, including managing multiple projects. She has working knowledge of FDA/ICH GLP and GMP guidelines and has proven experience with cell-based potency assays, Cell-based neutralization assays, PK and immunogenicity ELISA used to support bioprocess techniques for large molecule therapeutics. Ms. Wise-Blackman also holds Research & Development expertise in High Throughput Screening, 7-transmembrane receptor binding assays, cell-based assays, cell culture, and ELISA. Ms. Wise-Blackman is gifted with excellent presentation skills as evidenced by numerous scientific speaking engagements and working knowledge of PMP principles. She was an invited lecturer for IBC and IVT conferences, 1999-2008.
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