FDAnews Announces -- The Business of Pharmacovigilance: Understanding REMS During a Public Health Emergency Webinar, May 12, 2020
Tuesday, May 5, 2020
How are one's risk evaluation and mitigation strategy being impacted by the COVID-19 pandemic? What one must know about the FDA's new guidance.
FALLS CHURCH, Va., April 28, 2020 /PRNewswire-PRWeb/ -- 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
https://www.fdanews.com/pharmacovigilance
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.
Interested in registering multiple sites?
Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally
to learn about our special multisite discount.
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
https://www.fdanews.com/pharmacovigilance
Tuition:
$287 per site
Easy Ways to Register:
Online: https://www.fdanews.com/pharmacovigilance
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
SOURCE FDAnews
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