CMC, Quality, GMP
The Regulatory CMC (Chemistry, Manufacturing and Controls) and Product Quality Track provides a comprehensive overview of risk-based approaches throughout the product lifecycle.
The scope of the track spans scientific understanding gained through product and process development to lifecycle expectations for Global Regulatory CMC submissions, CGMP, and Quality Systems. Sessions address the increasing regulatory complexity in development and manufacturing for worldwide markets, global harmonisation, early patient access, pandemic medicines, new technologies, emerging regulations and the increasing scrutiny of manufacturing operations and data.
Who is This Track Designed For?
Professionals involved in CMC regulatory affairs and policy, manufacturing, quality assurance, quality control, drug development and/or manufacturing for small molecule drugs, biologics, vaccines and all modalities (ATMPs, oligonucleotides, etc).
The online program is now available. Explore the rich content we offer across 10 thought leadership tracks.
Topic Leaders
Diane Wilkinson, PhD, RPh
Senior Director, Global CMC Regulatory Affairs
Astrazeneca, United Kingdom
Matt Popkin, PhD
Director, CMC Strategy
GlaxoSmithKline, United Kingdom
Agenda
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Day 1: Tuesday, March 29th
The Critical Role of CMC in Early Patient Access For Unmet Medical Need
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Day 2: Wednesday, March 30th
Innovation in ICH and Other Quality Guidance
New Technologies in Manufacturing and CMC
Proactive Clinical Quality Assessment of Risk
Novel Regulatory, Science and Risk-Based Approaches for Management of Post-Approval Changes
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Day 3: Thursday, March 31st
DIA Europe 2022 Highlights
It will provide updates on key developments on the GCP Renovation (ICH E6, ICH E8), Clinical Trial Regulation, the Clinical Trial Information System, data submission, transparency, navigating ethical approval, study design in the digital age, innovative clinical trial designs (umbrella and platform trials, patient centricity), digital tools in development and other hot topics. It should be a must-attend for optimising development programmes and identifying cost savings through efficiency and innovation.