PROGRAM CO-CHAIRPERSONS:

Gary M. Gensinger: Deputy Director, Office of Business Informatics, CDER, FDA

Laura J. Sherman, MBA: Managing Partner, Distributed Compliance Solutions, LLC

Nancy Smerkanich: Vice President, Global Regulatory Affairs, Octagon Research Solutions, Inc.

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PROGRAM COMMITTEE:

Dan P. Clark: Senior Manager, Strategic Regulatory Innovation, Novo Nordisk

Betsy Fallen: Lead, Global Essential Document and Supply Chain Management, Global Clinical Trial Operations, Merck & Co., Inc.

Stephanie Gleissner, MBA: Advisor- R&D IT, Eli Lilly and Company

Mark Gray: Director, Division of Data Management Services and Solutions, Office of Business Informatics, CDER, FDA

Virginia Hussong: Team Leader, Electronic Submission Support, Office of Business Informatics, CDER, FDA

Daniel F. Orfe, MS: Associate Director, Global Regulatory Operations – Technology, Standards & Vendor Management, Teva Pharmaceuticals

Cynthia F. Piccirillo: Director, Global Dossier Management eStrategy, Bristol-Myers Squibb Company

Sarah Powell: Executive Director, Regulatory Affairs and Writing Services, Liquent, Inc.