Track 10: Regulatory CMC and Product Quality
The Regulatory CMC and Product Quality Track has 10 sessions and provides a comprehensive view of risk-based approaches across the product lifecycle. With themes in CMC, Product Quality, New Technology and Innovation, FDA Initiatives, and International Harmonization, 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 will 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.
Included Topic Areas in Regulatory CMC and Product Quality
DIA 2018’s Program and full list of sessions will be available in January. Meanwhile, see what topics and priorities we are designing content for.
- Opportunities for streamlining post approval life cycle management under ICH Q12
- CMC challenges for breakthrough therapies and other worldwide accelerated approval programs
- Expectations for ICH M9 “Biopharmaceutics Classification System Based Biowaivers”
- Global implementation of new technologies
- Modernizing and harmonizing inspectional approaches
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.