Curriculum
Course Description:
Oligonucleotide drugs are a special class of therapeutics that are not explicitly cover by the regulatory and CMC guidances that cover low molecular weight therapeutics. This presentation will discuss some of the regulatory challenges for synthetic oligonucleotides seen in INDs and NDAs. In particular, the CMC issues for Manufacturing, Characterization and Control of Drug Substance will be discussed.
This recording features
a presentation by Lawrence Perez, Ph.D.
Who should participate:
- Analytical chemists
- QA/QC analysts
- R&D scientists, managers
- Team members in CMC development projects
- Manufacturing scientists, managers
- Regulatory affairs specialists
- Contract research organizations
- Contract manufacturing organizations
Access Duration:Access to this course expires 6 months from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.