返回 Agenda
Session 9 Track 1: The Only Constant is Change; How Will Emerging Data Standards Affect Global Regulatory Processes
Session Chair(s)
Jo English
VP and General Manager, Enterprise Technology
Calyx, United Kingdom
Regulatory Operations is continually being challenged with new standards and data requirements from global health authorities. Join the panel of experts to understand how some of the latest standards (PQ-CMC, KASA) will impact your business processes and what you can do to start planning for their implementation. The panel will build on your knowledge of these emerging standards and take a deep dive to understand the true business implications.
Learning Objective : At the conclusion of this session, participants should be able to:
- Clearly understand PQ-CMC and KASA data standards
- Understand how these standards will impact current business process
- Review and update current business process
Speaker(s)
PQ-CMC and Its Interaction with IDMP and Other Emerging Standards
Karen Harry
Viatris, United Kingdom
Senior Manager Regulatory Initiatives
Identifying the Business Impact of PQ-CMC
Rodrigo Palacios, MBA
F. Hoffmann-La Roche, Switzerland
Regulatory Policy Lead
Overview of KASA and Its Implications on Current Business Process
Vada A. Perkins, DrSc, MSc
Boehringer Ingelheim, United States
Vice President, Global Head of Regulatory Intelligence & Policy