戻る Agenda
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)
Changing Drug Development Paradigms and Considerations for Quality Systems
Kirsten Ledwith Morasco
Compliance Implementation Services (CIS), United States
Vice President, Clinical and Quality Compliance
Panelist
James R. Dixon
PPD, United States
Senior Vice President, Quality and Enterprise Learning
Panelist
Mike Sobczyk, MSc
Gilead Sciences, Inc., United States
Exec. Director, R&D Quality and Compliance
Panelist
Marcia K. Horn, JD
ICAN, International Cancer Advocacy Network, United States
President and CEO