Course Description
This course offers a comprehensive understanding of the guidelines and regulations governing drug approval processes. It covers key topics such as healthcare regulations, CTD structure, NDA/EMA submissions, approval timelines, accelerated pathways, priority review, and the approval of generics and biosimilars, with a focus on major regulatory authorities like the FDA and EMA.
What You’ll Learn?
- Understand the regulatory guidelines governing drug approval processes
- Learn about common technical document (CTD) structure and NDA/EMA submission requirements
- Gain insights into approval timelines, accelerated pathways, and priority review processes
- Explore the regulatory approval process for generics and biosimilars under major authorities like the FDA and EMA
