Course Description:
Oligonucleotide drugs are a special class of therapeutics that are not explicitly covered by the regulatory and CMC guidance which cover low molecular weight therapeutics. This presentation discusses some of the regulatory challenges for synthetic oligonucleotides seen in INDs and NDAs. In particular, the regulatory issues for Manufacturing, Characterization and Control of Drug Substance are discussed.
Who should participate:
- Regulatory scientists
- Analytical scientists
- Quality assurance analysts
- R&D scientists and managers
- Quality control analysts
- Contract research organizations
The live version of this recording took place during the USP Workshop on Therapeutic Peptides and Oligonucleotides: Regulations and Quality Standards on April 9-10, 2024 and features a presentation by Lawrence Perez.
Access Duration:
Access to this course expires 60 days from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.