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

U.S. Food & Drug Administration
Nov. 13–15, 2018

Tommy Douglas Conference Center
10000 New Hampshire Avenue
SIlver Spring, MD 20903

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Experts from FDA’s Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH), the University of Maryland and the University of Pennsylvania will provide a deep dive into the scientific background and practical methodology needed when conducting clinical trials.

In this intensive course, attendees will learn FDA regulations, ethical considerations, and the scientific principles to help them understand what is important when conducting clinical trials and preparing a submission for FDA review.

About the Training Course

Topics include:

  • Preclinical and clinical science
  • Statistical structure of trials
  • Safety and ethical requirements
  • FDA regulatory requirements related to the performance and evaluation of clinical studies
  • Non-clinical, early clinical, and phase 3 studies
  • Issues in the design and analysis of trials

After this course, the participant will be able to:
1. Explain the responsibilities of an investigator conducting a clinical trial
2. Describe what to look for in medical products being studied in a clinical trial
3. Describe the basic concepts of clinical trial design
4. Review clinical data for sources of bias and error

Registration

Onsite attendance only. This event will NOT be webcast. Registration closes on Nov 6, 2018 or when registration is full.

Register here.

Posted: Sept. 24, 2018