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Regulatory Due Diligence for FDA Regulated Companies

Presented by Darshan Kulkarni

(4 Ratings)

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Course Description

Length: 59min    Published: 4/9/2024    
Join this Continuing Legal Education (CLE) session to get the latest insights and updates on how to effectively conduct due diligence for acquisitions in the life sciences sector, considering the dynamic legal, regulatory, and compliance environment. Key Topics: - DOJ, OIG, and ORI investigations impact: Discover how recent actions and advisories from the Department of Justice (DOJ), Office of Inspector General (OIG), and Office of Research Integrity (ORI) influence due diligence efforts. We'll cover crucial aspects such as adherence to the False Claims Act, the integrity of clinical trial data, and handling of research misconduct. - Updates on FDA regulations: Dive into the most recent changes and enforcement actions by the Food and Drug Administration (FDA) and understand how they alter the risk landscape for potential acquisitions. -New legal and regulatory developments: Unpack the latest trends in the life sciences sector, including CRAACO, decentralized studies, and others, and how to evaluate the compliance risks they present.
Learning Objectives
* Master the current legal and regulatory framework affecting life sciences acquisitions due diligence
* Build essential skills for spotting and evaluating risks in life science companies
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Presented By:

Darshan Kulkarni

Rydal, PA


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