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Education Details

The Pharmaceutical industry has seen a significant increase in the outsourcing of the development and manufacturing of drugs. It is imperative that regulators, owners and contract service providers understand, align and comply with applicable regulations and good practices to assure high quality, consistent, safe and effective drugs for our patients.

View the Agenda ( 633 KB)

Conference Chair

 PhotoTim Tyson
Chairman and CEO, Aptuit, Inc.

Co-Chairs

 PhotoSteve Leonard
Sr. VP of Global Operations, Catalent Pharma Solutions

 PhotoPaula Katz, JD
Regulatory Counsel and Sr. Policy Advisor, FDA

Plenary Session 

Speakers

 PhotoSteve Leonard
Sr. VP of Global Operations, Catalent Pharma Solutions

CMO Expectations and Challenges of Contracted Work

Michael Levy
Senior Counsel, OC/CDER/OMPT, FDA

The Regulatory Expectations and Challenges of Contracted Work

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