Track 10: Regulatory CMC and Product Quality
The Regulatory CMC and Product Quality Track provides a comprehensive view of risk-based approaches across the product lifecycle. The track scope spans from the 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 of development and manufacturing for worldwide markets, accelerated development timelines, new technologies, emerging regulations, and increased scrutiny of manufacturing operations and data.
Sessions in Regulatory CMC and Product Quality
Monday, June 28
- Defining Quality for Cell and Gene Therapy Products
- Advancing ICH Quality Standards to Support Continual Improvement and Innovation in Manufacturing Technologies and Approaches
- Implementation Progress of ICH Q12
Tuesday, June 29
- Modernizing CMC Dossier Format and Review
- Supporting Quality/CMC Development in Early Access Approaches (PRIME/Breakthrough Designation)
- Multinational Collaborative CMC Review for Efficient and Rapid Product Approval
Wednesday, June 30
- COVID-19 Pandemic and Beyond: Current Status and Learnings from Remote GMP Assessments
- Nitrosamines: What We Have Learned as Regulators and Industry Professionals for a New Path Forward
Thursday, July 1
- How to Avoid Shortages? Insights from the EU Executive Steering Group on Shortages – Learnings from the COVID-19 Pandemic
- Mobilizing Manufacturing: Portable and Point of Care Manufacture of Medicines
Who is This Track Designed For?
Professionals involved in: regulatory affairs, manufacturing, quality assurance, quality control, drug development and/or manufacturing for small molecule drugs, biologics, and vaccines.