Drugs

Regulatory Education for Industry (REdI): Clinical Investigator Training Course (CITC) 2018

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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)

November 13-15, 2018

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

Agenda (PDF - 156 KB)

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

Location

Tommy Douglas Conference Center (TDCC)
10000 New Hampshire Avenue, Silver Spring, MD 20903

Who Should Attend?

Physicians, nurses, pharmacists and other healthcare professionals responsible for the conduct in clinical trials.

Speakers

FDA medical officers, FDA senior scientists, FDA senior experts, and guest lecturers from academia and patient advocacy will provide presentations.

Questions

Contact us with questions at ClinicalInvestigator@fda.hhs.gov or at 301-796-8946.

Continuing Education

This event is eligible for up to 12 credits towards a RAC recertification.

A collaborative partnership between the University of Maryland, College Park and the University of Maryland, Baltimore, with support from the Food and Drug Administration (FDA), the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) focuses on modernizing and improving the ways drugs and medical devices are reviewed and evaluated.

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Page Last Updated: 09/20/2018
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