Track 10: Regulatory CMC and Product Quality
The Regulatory CMC and Product Quality Track has multiple 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.
Sessions in Regulatory CMC and Product Quality
Monday, June 24
- Update on ICH Quality Topics
- Regulating Innovation in Chemistry, Manufacturing, and Controls: Challenges and Opportunities
Tuesday, June 25
- Quality Considerations for Complex Generics
- Where Quality Meets Safety and Efficacy: A Conversation with CMC Experts
- Where Quality Meets Safety and Efficacy: An Interactive Experience
- Integration of Manufacturing Quality Assessment and Pre-Approval Inspections
Wednesday, June 26
- Measuring and Assessing Product Manufacturing Quality
- Efficient Preparation of Global CMC Dossiers
- Challenges and Opportunities in Product Quality: Lifecycle Management
- Case Studies in Resolving Quality Issues
Thursday, June 27
Take a look at and hear from our top 5 attended regulatory sessions from DIA 2018. Download the recordings here.
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.