Regulatory: US preclinical study of cellular and gene therapies

About course

This free interactive course provides a high-level overview of preclinical study in cellular and gene therapy (CGT) development. Understanding the US FDA regulatory requirements for designing and planning your preclinical study for CGTs is especially important due to the nature and number of risks to the patients using these products.

Key learnings:

- Understanding why the preclinical study phase is so important

- Identifying the US FDA regulatory requirements for preclinical study in CGTs

- Designing and planning your preclinical study

After diving into the details, you’ll hear from an expert 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 20 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.