Current CMC Regulatory Experiences and Expectations for Oligonucleotides (On-Demand)

Curriculum

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 on during the USP Workshop on Therapeutic Peptides and Oligonucleotides:
Regulations and Quality Standards on February 28, 2022

Access Duration:
Access to this course expires 60 days from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.

Speakers:
René ThürmerThürmer, Ph.D.
BfArM, Germany