On-demand webinar
Regulatory Feedback on Late-Stage Programs
A CDMO Perspective
Explore regulatory feedback relevant to Phase III and commercial oligonucleotide programs, with a CDMO perspective on manufacturing and analytical requirements.
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About this webinar
Advancing an oligonucleotide therapeutic into late-stage development brings regulatory and validation questions into sharper focus. This webinar examines molecule classification, process validation and regulatory expectations from a CDMO perspective. It also considers the role of release specifications and analytical method validation in Phase III and commercial programs.
What you’ll learn
- How molecule classification shapes regulatory discussions.
- Process validation considerations for late-stage programs.
- The role of release specifications in assessing product quality.
- Analytical method validation considerations for Phase III and commercial supply.
Who is it for?
Teams working in CMC, regulatory affairs, quality, process development and analytical development for late-stage oligonucleotide programs.