CMC Regulatory Considerations for Oligonucleotides and Peptides: Similarities and Differences (On-Demand)


Course Description:
This presentation will provide an overview what can oligonucleotide and peptide developers learn from each other in their regulatory experiences, regardless of whether they are working on an oligonucleotide or a peptide. Common CMC issues that face both groups will be highlighted and experiences from recent regulatory submissions will be discussed.

The live version of this recording took place on March 1, 2021 and features
a presentation by René Thürmer, 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 60 days from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.