Postapproval Change Management: Challenges and Opportunities

Track:
Pharmaceutical Quality

Day & Time:
June 27, 9:00AM - 10:30AM

Session Number:
410

Room Number:
153C

Level:
Intermediate

Type:
Session

Title:
Postapproval Change Management: Challenges and Opportunities

Chair(s):
Christine M. V. Moore, PhD
Acting Director, Office of New Drug Quality Assessment, OPS, CDER
FDA, United States

Description:
A robust postapproval global change management program is an essential part for any pharmaceutical quality system. This session will discuss the importance of a robust and current global change management system and the challenges and opportunities faced by both the pharmaceutical sector as well as the regulatory agencies.

Learning Objective(s):
Describe the importance of a robust change management system; Discuss the challenges and opportunities in maintaining and utilizing a robust global change management system.

Presentation(s) & Speaker(s):
Postapproval Change Management Protocols: Facilitating Regulatory Flexibility
Evdokia Korakianiti, PhD,MSc
Head of Chemicals Section, Quality of Medicines
European Medicines Agency, European Union , United Kingdom