Regulatory Affairs

Office of the Vice President and Innovation

  • November 12-14, 2019
  • The Hotel at the University of Maryland, College Park, MD
  • The course fee is $500 and includes attendance to program sessions, coursebook with all speaker slides, breakfast on November 12-14, and daily refreshment breaks. A room block is available for the rate of $179/night

This course provides a 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.

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 the value of this course, it is recommended that 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 include subject matter experts from CDER, CBER, and CDRH, academia, and representatives from patient advocacy organizations.


  1. Centers of Excellence in Regulatory Science and Innovation (CERSI)
  2. 2018 Clinical Investigator Training Course


E-mail or call 301-796-8946.

Continuing Education

This course:

  • 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.
  • 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.
Categories FDA Regulatory
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