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Session 3: The future of CMC Submissions: Digital Data Dossier
Session Chair(s)
Ben Thompson
Vice President, CMC and Non-clinical Regulatory Affairs, GlaxoSmithKline, United Kingdom
Henrik K. Nielsen, PHD, MBA, MSC
Vice President, Novo Nordisk A/S, Denmark
The future of CMC Submissions: Digital Data Dossier
Speaker(s)
FDA’s New Quality Initiative: Knowledge-aided Assessment and Structured Application (KASA)
Director, Office of New Drug Products, OPQ, CDER, FDA, United States
Update on ICH M4Q Progress and Industry Perspective
Vice President, Novo Nordisk A/S, Denmark
Modernizing CMC Data Exchange: A Cloud-Based Approach to Structured Data and Content Management
Associate Director, Global Regulatory Affairs (CMC), Amgen, United States
Modernizing CMC Data Exchange: A Cloud-Based Approach to Structured Data and Content Management
Senior Director, Technical Regulatory Policy, F. Hoffmann-La Roche Ltd., Switzerland
Change Assessment Knowledge Engine (CAKE): Accelerating Regulatory CMC Assessments of Proposed Changes
Associate Principal Scientist, Site CMC, Merck Sharp & Dohme, Netherlands
Change Assessment Knowledge Engine (CAKE): Accelerating Regulatory CMC Assessments of Proposed Changes
, MSD, United States
ICMRA-ICH-PIC/S-IPRP Joint Reflection Paper on PQ KMS Capability
Senior Director, CMC Excellence, Global Regulatory Affairs, GSK, United Kingdom
Panel discussion with Q&A
Expert, Saudi Food and Drug Authority, Saudi Arabia
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