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Wednesday, June 29 • 10:30am - 11:30am
#318: Changes to Common Rule Likely Affecting FDA-Governed Research

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Limited Capacity seats available

Component Type: Session
Level: Advanced
CE: CME 1.00; IACET 1.00; RN 1.00

Although the Common Rule for research does not govern FDA governed clinical investigations, the proposed changes likely will eek over into FDA governed research. This session explores those proposed changes and their expected effects.

Learning Objectives

List key proposed changes to the Common Rule for Research; Contrast changes to FDA's requirements; Hypothesize how changes will affect FDA governed research.

Chair

David Vulcano

Speaker

Industry Perspective
David Vulcano

Industry Perspective
Neil McCullough



Chair
avatar for David Vulcano

David Vulcano

Vice President, Clinical Research Compliance & Integrity, Hospital Corporation of America (HCA)
David is a well-known leader in the clinical research industry through numerous associations, boards and initiatives. Among other things he is currently employed by HCA, the largest private healthcare provider in the United States, as the Responsible Executive for Clinical Research... Read More →

Speakers
NM

Neil McCullough

Executive Vice President, Clinical Quality Compliance, ICON Clinical Research
Dr. McCullough has vast experience leading global quality and compliance teams within the industry. His expertise in quality assurance, regulatory affairs, risk-based auditing, continuous improvement, and project management are relied upon by PPD and its clients to achieve high quality... Read More →


Wednesday June 29, 2016 10:30am - 11:30am
202AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA