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FDAnews Announces — The Business of Pharmacovigilance: Understanding REMS During a Public Health Emergency Webinar, May 12, 2020

The Business of Pharmacovigilance
Understanding REMS During a Public Health Emergency
An FDAnews/CenterWatch Webinar
Tuesday, May 12, 2020 • 1:30-3:00 p.m. EDT

How does one handle risk evaluation and mitigation strategy (REMS) programs in the age of COVID-19?

The FDA just issued guidance related to pharmaceutical sponsors who fail to meet certain REMS requirements during the COVID-19 outbreak. They won’t face FDA enforcement action. This guidance will remain in effect until the public health emergency is over.

During the pandemic one may find it difficult to complete some program activities such as finish lab tests or imaging studies required by REMS as patients self-isolate or are quarantined. How should one proceed?

Catherine Baldridge, MS, owner/founder of Essential Pharmacovigilance, LLC, will cover REMS critical components, explain the importance of advanced planning and proper resource allocation to prepare one for the ultimate success of one’s REMS programs during this public health emergency:

  • Specific elements to assure safe use (ETASU) in one’s REMS
  • Recommended lead time for preparing for a REMS program in order to provide adequate scheduling for companies and contract research organizations
  • Recommended quality and compliance processes one needs to consider during an implementation
  • Importance and value of cross-functional engagement when developing and implementing a program
  • Impact of the program on the global pharmacovigilance (PV) system, including financial impact, 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) one must know for implementing and managing a program

This is the first time this topic is being addressed from an industry perspective. If one is planning for a REMS this opportunity is critical.

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Webinar Details:
The Business of Pharmacovigilance
Understanding REMS During a Public Health Emergency
An FDAnews/CenterWatch Webinar
Tuesday, May 12, 2020 • 1:30-3:00 p.m. EDT

$287 per site

Easy Ways to Register:
By phone: 888.838.5578 or 703.538.7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations

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