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Regulatory, Clinical, and Quality Challenges in Contracting and Due Diligence: The Forgotten Keys to Biopharma Transactions
Session Chair(s)
Michael Swit, JD
Senior Director, Legal, Regulatory Affairs
Varian, United States
This session will provide drug professionals with a deeper understanding of the key regulatory, clinical or quality issues that must be reviewed in buying a biopharmaceutical product or company and how to address those concerns in the due diligence phase
Learning Objective : Discuss the types of critical regulatory, clinical and quality issues that MUST be reviewed before deal closing; Describe how to structure due diligence teams, using internal and external resources, and how to review key issues cost effectively.
Speaker(s)
Navigating Potential Regulatory Land Mines in Due Diligence
Gregory E Dombal
Halloran Consulting Group Inc., United States
Chief Operating Officer
Quality Challenges in Due Diligence
John C. Garvey
Compliance Architects LLC, United States
Principal
Clinical Challenges in Due Diligence
Ann Begley, BSN, JD
Wiley Rein LLP, United States
Partner
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