戻る Agenda
Quality Metrics: The Carrot or the Stick?
Session Chair(s)
Sarah Pope Miksinski, PHD
Executive Director, CMC Regulatory Affairs
Gilead Sciences, United States
Subsequent to the recently-revised (November 2016) Quality Metrics draft guidance, industry and regulatory experts will address the benefits and challenges posed by the newly revised draft guidance for various segments of the pharmaceutical industry, proposed solutions, different approaches to metrics analysis and implementation, and the quality culture as part of the metrics equation.
Learning Objective : Discuss the advantages and disadvantages of the updated Quality Metrics draft guidance on the pharmaceutical industry
Speaker(s)
Industry Perspective
Steven Mendivil
Amgen Inc., United States
Senior Advisor International Quality
Industry Perspective
Michael G. Davidson
Pfizer Inc., United States
Vice President, Quality Systems and Compliance
Industry Perspective
Barbara Allen, PHD
International Quality Expert, United States
Panelist
Tara Gooen Bizjak, MS
FDA, United States
Regulatory Officer, OC, CDER
Panelist
Alex M. Viehmann
FDA, United States
Operations Research Analyst, OS, OPQ, CDER