Janet Woodcock is the director of the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA). The center makes sure that safe and effective drugs are available to improve the health of people in the United States.
March 18 - 21, 2014 - Cintas Center at Xavier University
The PharmaLink conference seeks solutions to important and complicated issues by aligning with the strategic priorities of the Food & Drug Administration. We help participants create links to drive new thinking. The solutions might not be evident within our industry, so we explore beyond industry, beyond borders, and beyond comfort zones. Don’t miss this opportunity to join your colleagues and global regulators from around the world so you can make a meaningful difference for your organization and our industry. PharmaLink actively fosters engagement among all participants and regulators, so true opportunity for change can be identified.Learn More
Kathleen has been with FDA for 20 years as a Chemist in the Southeast Regional Laboratory, an Investigator in Atlanta District and an Investigator and Drug Preapproval Manager in Cincinnati District.
Michael Davison has over 27 years of experience in the Pharmaceutical Industry, he is an analytical chemist by training and joined Pfizer in 1986.
Deborah Autor will be participating at the 2014 PharmaLink Conference. Autor joined Mylan from the U.S. Food and Drug Administration (FDA), where she served for 11 years, most recently as Deputy Commissioner for Global Regulatory Operations and Policy.
Mullen joined Patheon in 2011 as Chief Executive Officer. Prior to joining Patheon, he served as CEO and President at Biogen Idec Inc. from 2003 to 2010, one of the world’s largest biotechnology companies.
Ms. Fionnuala Walsh, PhD has been Senior Vice President of Global Quality at Eli Lilly & Co. since July 2007.
Dr. William K. Fleming is President of Humana Pharmacy Solutions, an 11 million member health benefits organization.
Join us as James Mullin, CEO of Patheon, shares his thoughts on how all players in the complex global supply chain have a vital and interdependent leadership role in ensuring our medicines are safe and effective for patients around the world. The evening event will be held at Great American Ball Park which serves as […]
Quality is critically important in the pharmaceutical industry. Before we race to implement better systems, we first need to establish a clear quality standard, one that benefits patients and companies. CDER is challenging companies to gain an “A” status. Achieving this status will reward companies who are most successful at operationalizing high standards of quality […]