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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 Sciences, 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
Andrew Chang, PhD
Novo Nordisk, United States
Vice President, Quality and Regulatory Compliance
Panelist
Ciby Joseph Abraham, PhD
AstraZeneca, United States
Senior Director and Group Manager, Project and Product Leadership
Panelist
Alexander Gaffney, MS, RAC
AgencyIQ by POLITICO, United States
Executive Director, Regulatory Policy And Intelligence
Panelist
Lawrence Yu, PhD
FDA, United States
Director, Office of New Drug Products, OPQ, CDER
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