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Regulatory, Clinical, and Quality Challenges in Contracting and Due Diligence: The Forgotten Keys to Biopharma Transactions
Program Code:
243
Date:
Tuesday, June 25, 2013
Time:
1:45 PM to 3:15 PM
EST
CHAIR
:
Michael A. Swit,
Esq, JD (SCHNON), Special Counsel,
Duane Morris, LLP, United States
Michael Swit has solved vital FDA legal issues since 1984. Before joining Duane Morris, he was: VP at The Weinberg Group; with 3 major FDA law firms, general counsel of Par Pharmaceutical; and CEO of FDANews.com. He graduated magna cum laude from Bowdoin College and got his law degree at Emory U.
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SPEAKER
(S):
Ann Begley, BSN,JD (SPKNON), Partner, Morgan, Lewis & Bockius, LLP, United States
Gregory Dombal, Managing Partner, Halloran Consulting Group Inc.
John C. (Jack) Garvey, (SPKNON), Principal, Compliance Architects LLC, United States
Description
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