Clinical Investigator Training Course

Silver, Spring, MD | November 13-15, 2018

Online registration will close at 11:59PM ET, Tuesday, November 6, 2018 or when registration is full.

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.

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

Learn more and register.

A collaborative training course hosted by the U.S. Food and Drug Administration, Center for Drug Evaluation and Research’s (CDER’s) Office of Medical Policy (OMP), Small Business and Industry Assistance (SBIA) and University of Maryland’s Center of Excellence in Regulatory Science and Innovation (CERSI).

The University of Alabama at Birmingham
1313 13th Street South, OSB 3rd Floor
Birmingham, AL 35205
Telephone: (205) 996-0832

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