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Adapting GCPs to Evolving Drug Development Paradigm (Part 1 of 2)
Session Chair(s)
Shaghig Palanjian, MBA
Vice President, Global Head, R&D QA and Compliance , Shire, United States
The session will focus on the changing product development paradigm and considerations for quality systems, QA audits, and GCP compliance considerations, as we see the shift in industry to personalized medicine, increased focus on rare diseases, and the new technologies. We will review the point of view from sponsor, service provider (CRO) and QMS design perspectives, and how it impacts GCP compliance when we work with smaller patient populations, limited number of investigators within disease areas, limited data and data sources etc., as we see shifts in the development paradigm and regulatory framework.
Part 2 will take place on Tuesday at 3:30 pm (Session #295).
Learning Objective : Develop strategies for the design, implementation, and auditing consideration of GCP Compliance; Discuss company QMS needs in the changing product development paradigm.
Speaker(s)
Kirsten Ledwith Morasco
Vice President, Clinical and Quality Compliance, Compliance Implementation Services (CIS), United States
Changing Drug Development Paradigms and Considerations for Quality Systems
James R. Dixon
Senior Vice President, Quality and Enterprise Learning, PPD, United States
Panelist
Mike Sobczyk, MSC
Exec. Director, R&D Quality and Compliance, Gilead Sciences, Inc., United States
Panelist
Marcia K. Horn, JD
President and CEO, ICAN, International Cancer Advocacy Network, United States
Panelist
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