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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)
Lawrence Yu, PhD
FDA, United States
Director, Office of New Drug Products, OPQ, CDER
Update on ICH M4Q Progress and Industry Perspective
Henrik K. Nielsen, PhD, MBA, MSc
Novo Nordisk A/S, Denmark
Vice President
Modernizing CMC Data Exchange: A Cloud-Based Approach to Structured Data and Content Management
Rita Algorri, PhD, MS
Amgen, United States
Senior Manager, Global Regulatory Affairs (CMC)
Modernizing CMC Data Exchange: A Cloud-Based Approach to Structured Data and Content Management
Rodrigo Palacios, MBA
F. Hoffmann-La Roche, Switzerland
Regulatory Policy Lead
Change Assessment Knowledge Engine (CAKE): Accelerating Regulatory CMC Assessments of Proposed Changes
Danny Verkooij
Merck Sharp & Dohme, Netherlands
Associate Principal Scientist, Site CMC
Change Assessment Knowledge Engine (CAKE): Accelerating Regulatory CMC Assessments of Proposed Changes
Amy Keegan
MSD, United States
ICMRA-ICH-PIC/S-IPRP Joint Reflection Paper on PQ KMS Capability
Matt Popkin, PhD
GSK, United Kingdom
Senior Director, CMC Excellence, Global Regulatory Affairs
Panel discussion with Q&A
Saeed Al Awadh
Saudi Food and Drug Authority, Saudi Arabia
Expert
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