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Wednesday, June 29 • 2:00pm - 3:15pm
#337: Overcoming Deficiencies in the Oversight of Outsourced Clinical Programs: Collaboration and Utilization of Industry Leading Guidelines and Tools

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Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

This forum will present data on industry challenges/opportunities for improvement in sponsor oversight of CROs and service providers. Collaborative efforts for developing and implementing industry leading practice guidelines and tools will be shared.

Learning Objectives

Discuss the oversight requirements and expectations from regulators, sponsors and providers; Explain the collaborative effort to develop and utilize industry leading practices for the oversight of outsourced clinical programs; Demonstrate examples of vital guidelines and tools for achieving top-tier success through appropriate oversight practices.


Mike Collins, PhD


Grace M Crawford, MS

Joseph Anthony Fortunato

Steven B. Whittaker

avatar for Mike Collins

Mike Collins

Head of R&D Global Vendor Management, Alexion
Mike graduated from the University of Sheffield in the UK with a degree in Genetics. After an MSc in Applied Genetics; he completed his doctorate at the University of Birmingham. Mike has worked in clinical development for over 25 years at Hoechst and Pfizer. He is currently Head... Read More →

avatar for Grace Crawford

Grace Crawford

Global Head, Clinical Quality and Compliance, AstraZeneca
Grace joined MedImmune in April 2015 to lead the Clinical Quality & Compliance function. Prior to joining MedImmune, Grace spent over 21 years at ICON where her main focus was leading the Clinical QA Department. She is active in industry participating in forums such as the Society... Read More →
avatar for Joseph Fortunato

Joseph Fortunato

Senior Vice President, Corporate Quality Assurance and Compliance, inVentiv Health Clinical
Joseph Fortunato has over 37 years of experience in the healthcare industry with leadership roles in large pharma and large CROs. _x000D_ _x000D_ Joe joined inVentiv Health Clinical in 2014 as the Sr. VP of Corporate QA and is responsible for leading a group of Quality Assurance professionals... Read More →
avatar for Steven Whittaker

Steven Whittaker

Executive Director, Quality Consortium, The Avoca Group
Steven Whittaker, Executive Director, Avoca Quality Consortium (retired from Eli Lilly and Co.) , consults for the pharmaceutical, biotech, and CRO industries, providing expertise in project management, pharmaceutical development, clinical development, outsourcing strategies and execution... Read More →

Wednesday June 29, 2016 2:00pm - 3:15pm EDT
112AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 03: Innov Part Model-Outsourcing, Forum