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.
Subject area:
Biologics
Objectives (If applicable):
NA
Target Audience (If applicable):
QA Manager
QA Staff
QC Chemist
QC Manager
R&D
Regulatory
Student