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 15

• Gene Therapy Manufacturing: How Can Innovation Help Overcome this Anticipated Hurdle?

Tuesday, June 16

• Regulatory Agility During the COVID 19 Pandemic

Thursday, June 18

• ICH 30th Anniversary Series: International Harmonization for Pharmaceutical Quality

On Demand

• Demystifying Global Device Requirements: High-Level Comparison of Current Expectations
• N-Nitrosamines Contamination Case Lessons Learned
• Quality Considerations for Complex Drugs

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.

View Other Tracks

Registration Rates

Back to DIA 2020

Back to DIAglobal.org