Curriculum
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.
This recording 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 6 months from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.