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Session, 8 Track 4: Future-proofing Regulatory Affairs: Redesigning Operational Models in a Transformative Era
Session Chair(s)
Noelia Plaza
Director of Process Excellence & Analytics
Daiichi Sankyo, United States
Regulatory Affairs is undergoing a transformative shift necessitating a redesign in operating models. This session will convene leading experts from industry and regulatory agencies to explore critical considerations for designing optimal operational models. Together, we will establish guiding principles to future-proof regulatory groups and ensure they remain agile and effective in this evolving landscape. Effective upskilling strategies will be discussed, including training and development programs through in-house sessions, online courses, and partnerships with external providers.
Future-proofing Regulatory Affairs: Redesigning Operational Models in a Transformative Era - Helena Corte-Real Correia, F. Hoffmann-La Roche Ltd
BMS Case Study: Learning and Development as Catalysts for Regulatory Evolution - Sandra Krogulski, Bristol-Myers Squibb Company
Future-proofing Regulatory Affairs: Redesigning Operational Models in a Transformative Era - Hilmar Hamann, European Medicines Agency
Learning Objective : At the conclusion of this session, participants should be able to:- Understand the impact of technological and scientific advances on Regulatory Affairs
- Explore new forms of collaboration and partnerships emerging in Regulatory
- Identify key principles for future-proofing Regulatory groups
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Identify key areas where upskilling is essential along with best practices to achieve it
Speaker(s)
Future-proofing Regulatory Affairs: Redesigning Operational Models in a Transformative Era
Helena Corte-Real Correia, PHD
F. Hoffmann-La Roche Ltd., Switzerland
VP, Regulatory Data and Content Lead
BMS Case Study: Learning and Development as Catalysts for Regulatory Evolution
Sandra Krogulski, MA
Bristol Myers Squibb, United States
Director, GRSO Innovation and Business Operations Lead
Future-proofing Regulatory Affairs: Redesigning Operational Models in a Transformative Era
Hilmar Hamann, PHD
European Medicines Agency, Netherlands
Chief Information Officer