Ensure that clinical data withstands FDA and DOJ scrutiny, from preclinical development through clinical trials to market approval.
FALLS CHURCH, Va., Sept. 13, 2022 /PRNewswire-PRWeb/ -- The FDA's Focus on Clinical Data Integrity
Throughout Product Development and Approval
A WCG FDAnews Webinar
Wednesday, Sep. 21, 2022, 1:30 p.m.–3:00 p.m. EDT
https://wcg.swoogo.com/fdas-focus-on-clinical-data-integrity
Clinical data must withstand FDA and Department of Justice (DOJ) scrutiny from preclinical development through clinical trials and ultimately to market approval.
This webinar will show pharmaceutical and medical device manufacturers how to ensure their data integrity is accurate and reliable throughout the whole process.
Three members of King & Spalding's FDA and Life Sciences practice, two of whom are FDA veterans, will share what manufacturers must know and do to avoid data integrity-related FDA and DOJ enforcement action.
Beverly Lorell, senior medical and policy advisor, and partners Peter Leininger and Mark Brown will leverage hypothetical situations to highlight best practices for sponsors to identify and mitigate high-risk issues related to the integrity of clinical data. This includes its uses before and after product approval, as well as in crisis management. Attendees will learn:
- How disruptions brought on by the COVID-19 pandemic opened the door for unintended and deliberate breaches of the development of clinical data
- Recent trends in FDA warning letters that signal a shift from the agency's focus during the pandemic to the emerging "new normal" of scrutiny and inspections related to the development of clinical data and its integrity
- New modes of FDA enforcement, including those related to sponsor disclosure of clinical results on ClinicalTrials.gov
- Key fact patterns that may trigger a DOJ decision in collaboration with the FDA to initiate criminal prosecution of an individual or firm related to fraud or falsification of clinical data used to support an application, as well as debarment by the FDA
Webinar Details
The FDA's Focus on Clinical Data Integrity Throughout Product Development and Approval
A WCG FDAnews Webinar
Wednesday, Sep. 21, 2022, 1:30 p.m.–3:00 p.m. EDT
https://wcg.swoogo.com/fdas-focus-on-clinical-data-integrity
Price:
$287
Easy Ways to Order:
Online: https://wcg.swoogo.com/fdas-focus-on-clinical-data-integrity
By phone: 888.838.5578 or 703.538.7600
About WCG FDAnews:
WCG 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 WCG FDAnews' newsletters, books, databases, webinars and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations. Learn more at fdanews.com.
Media Contact
Michelle Butler, FDAnews, 703-538-7665, [email protected]
SOURCE FDAnews
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