Regulatory: eCTD submissions to the FDA
Course
About course
This free online course guides you through the format for electronic submissions to regulatory bodies, required for a new drug approval. In the long run, an accurate submission can help save your company time and resources.
Key learnings:
- Overview of the common technical document (CTD) format and the electronic version, eCTD
- The steps involved in an electronic submission to the US Food and Drug Administration (FDA)
- How to avoid technical problems
You’ll get insights on electronic submissions from one of our experts on the topic as well as find links to supporting resources. If you come across unfamiliar terms, check out the glossary of some key regulatory terms, processes, acronyms, and their definitions.
You can access and complete each lesson individually, with the full course taking around 15 minutes to complete.
Certification
You will get an online certificate after the course completion. You can view and download it in a section My Courses. With Cytiva Certificates, portions of our programs have been split into online modules, so you can earn a high quality knowledge in interactive format.
