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                CDER Small Business & Industry Assistance (SBIA)

CDER Small Business & Industry Assistance (SBIA)

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          CDER Small Business & Industry Assistance (SBIA)
          Regulatory Education for Industry (REdI): Clinical Investigator Training Course - Nov. 12-14, 2019CDER Small Business & Industry Assistance (SBIA) Regulatory Education for Industry (REdI): Clinical Investigator Training Course - Nov. 12-14, 2019
  
  	
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**Date and Time**

November 12-14, 2019
Tuesday, Wednesday,Thursday

**Location**

The Hotel at the University of Maryland
College Park, MD



**View Course Slides and Recordings** **Agenda**

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. ****

**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.****

**Resources**

Centers of Excellence in Regulatory Science and Innovation (CERSI)
	2018 Clinical Investigator Training Course**Questions**

E-mail ClinicalInvestigator@fda.hhs.gov 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.**M-CERSI**

*The*University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI), University of Maryland, and the FDA have partnered to modernize and improve the ways drugs and medical devices are reviewed and evaluated for licensure.

                                                                                  Content current as of:
      02/05/2020CDER Small Business & Industry Assistance (SBIA)

          
                        About CDER Small Business and Industry Assistance (SBIA)
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