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Adapting GCPs to Evolving Drug Development Paradigm (Part 1 of 2)

Track:
Innovative Approaches to Ensuring Quality in Clinical Trials and Compliance to Good Clinical Practice

Day & Time:
June 17, 1:30PM - 3:00PM (Pacific Standard Time)

Session Number:
271

Room Number:
8

Level:
Intermediate

Type:
Session

Title:
Adapting GCPs to Evolving Drug Development Paradigm (Part 1 of 2)

Chair(s):
Shaghig Palanjian, MBA
Head of Clinical and Medical QA and Compliance
Shire Pharmaceuticals, United States

Description:
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(s):
Develop strategies for the design, implementation, and auditing consideration of GCP Compliance; Discuss company QMS needs in the changing product development paradigm.

Presentation(s) & Speaker(s):
Changing Drug Development Paradigms and Considerations for Quality Systems
Kirsten Ledwith Morasco
Vice President, Clinical and Quality Compliance
Compliance Implementation Services (CIS), United States

Panelist
James R. Dixon
Senior Vice President, Global Quality and Compliance
PPD, United States

Panelist
Mike Sobczyk, MSc
Senior Director, Regulatory Compliance
Gilead Sciences, Inc., United States

Panelist
Marcia K. Horn, JD
President and Chief Executive Officer
International Cancer Advocacy Network (ICAN), United States