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