Course Description:
This presentation will provide an overview about the regulatory landscape for oligonucleotides. Issues related to the pharmaceutical quality of oligonucleotides are highlighted and experiences from recent regulatory submissions as well as current regulatory trends will be discussed.
Who should participate:
- QA Manager
- QA Staff
- QC Chemist
- QC Manager
- R&D
- Regulatory
- Student
The live version of this recording took place during the USP Workshop on Therapeutic Peptides and Oligonucleotides:
Regulations and Quality Standards.Access Duration:
Access to this course expires 6 months from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.
Speakers:
René ThürmerThürmer, Ph.D.
BfArM, Germany