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Data and Technology Influence on ICH Initiatives: M4Q(r2)/Q12 and Global Harmonization
Session Chair(s)
Brooke Casselberry, MS, RAC
Vice President, Advisory and Delivery, Epista Life Science, United States
Join industry leaders in this interactive forum to discuss the development of ICH initiatives ICH Q12 and ICH M4Q(r2), how they will impact the product approval lifecycle, and the technology that will manage these processes and the data.
Learning Objective : Describe important initiatives that will have a direct impact on the pharmaceutical product approval lifecycle; Identify how the initiatives will influence changes in our industry for patient-product access and faster approvals; Discuss how technology and data has a major role in bringing these initiatives to reality.
Speaker(s)
Panelist
Sr. Quality and Regulatory Compliance Director, Novo Nordisk A/S, United States
Panelist
Senior Director and Group Manager, Project and Product Leadership, AstraZeneca, United States
Panelist
Vice President, Regulatory Policy And Intelligence, AgencyIQ by POLITICO, United States
Panelist
Director, Office of New Drug Products, OPQ, CDER, FDA, United States
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