View the Feb. 2019 Course FilesView the Nov. 2018 Course FilesView the Nov. 2017 Course Files
Target Audience
This activity is intended for healthcare professionals (physicians, nurses, and pharmacists, clinical scientists); consultants; drug, device, and biologic industry employees; regulatory affairs professionals; and biomedical professionals.
Additional Training
Looking for more training?  The University of Maryland online MS in regulatory science degree program provides graduates with the knowledge and skills necessary to contribute to drug and biologics regulation and pharmaceutical product lifecycles.  Designed for working professionals, the degree program is exclusively online and is part-time over two years.  More information is available online.

2019 Regulatory Education for Industry (REdI): Clinical Investigator Training Course 

The Regulatory Education for Industry (REdI): Clinical Investigator Training Course  will take place on November 12-14, 2019. The event will be held in College Park, MD. There is no cost to attend in-person or remotely, but all participants must register. Additional details, including a full agenda, will be announced soon.

This course provides an intermediate-level study of clinical trial principles with in-depth coverage of clinical trial design, issues in safety and efficacy, investigator responsibilities, understanding the investigator brochure, and FDA requirements across Centers. Upon completion, attendees should understand pre-clinical research, clinical trials, and FDA submissions for licensure of medical products.   

Registration is now open.