Regulatory Education for Industry Clinical Investigator Training Course | A. James Clark School of Engineering, University of Maryland

Regulatory Education for Industry Clinical Investigator Training Course

Tuesday, November 12, 2019
University of Maryland, College Park
(301) 796-8946
ClinicalInvestigator@fda.hhs.gov

The Regulatory Education for Industry (REdI): Clinical Investigator Training Course will be held Nov. 12-14, 2019, in College Park, MD.
 
Registration is now open. More information will be shared as the agenda is finalized.
 
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.   

About the Training Course

Topics include:

  • Clinical trial design and analysis, including new trends and key documents such as: protocol, informed consent, investigator’s brochure, health records, and study reports
    Safety and efficacy requirements
  • Ethical considerations
  • FDA regulatory requirements related to the performance and evaluation of clinical studies
  • Non-clinical, early and advanced clinical studies
  • Roles and responsibilities of the investigator
  • Rationale for Good Clinical Practice (GCP), FDA regulations and inspections
  • Basic statistical principles

Who Should Attend?

To maximize value of this course, we recommend attendees possess a basic understanding of clinical trials, regulatory requirements and medical product development. Those who are involved in the clinical trial enterprise and are:
  • Healthcare professionals (physicians, nurses, and pharmacists, clinical scientists)
  • Consultants
  • Drug, device, and biologic industry employees
  • Regulatory affairs professionals
  • Biomedical professionals

Learning Objectives

  • Explain the responsibilities of an investigator conducting a clinical trial.
  • Describe what to look for in drugs being studied in a clinical trial.
  • Describe the basic concepts of clinical trial design.
  • Review clinical data for sources of bias and error.

Speakers

Speakers include subject matter experts from CDER, CBER, and CDRH, academia, and representatives from patient advocacy organizations.

Questions

E-mail ClinicalInvestigator@fda.hhs.gov or call (301) 796-8946.

Continuing Education

SOCRA accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.

This course:

  • has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.
  • has been pre-approved by SQA as eligible for 0.25 non-GCP or non-GLP units for every 1 hour of instructional time towards a participant’s RQAP re-registration.
  • has been approved by ACRP for medical education credits. Contact hours are provided at 1 unit for at least 45 minutes of qualified material.

 

 

Audience: Public  Clark School 

 

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