U.S. flag An official website of the United States government
  1. Home
  2. Drugs
  3. News & Events for Human Drugs
  4. FDA Clinical Investigator Training Course (CITC) 2022 - 12/07/2022
  1. News & Events for Human Drugs

Virtual

Event Title
FDA Clinical Investigator Training Course (CITC) 2022
December 7 - 8, 2022


Date:
December 7 - 8, 2022
Day1:
- ET
Day2:
- ET


Agenda

Visit CDER Small Business and Industry Assistance Page

ABOUT THIS CONFERENCE

This course is designed to promote professionalism in the clinical trial industry for individuals involved with FDA submissions (Investigational New Drug (IND) Application, New Drug Application (NDA), Biologic License Application (BLA), and Investigational Device Exemption (IDE)), and to familiarize stakeholders with the regulatory and scientific issues involved in the development and approval of medical products. Participants will acquire a practical understanding of FDA’s approach to the evaluation of clinical trials, associated regulatory requirements, and other scientific issues related to investigational medical products.

TOPICS COVERED

  • Design and conduct of clinical trials
  • Determining appropriate endpoints in clinical trials
  • Efforts to advance diversity in trial populations
  • Statistical evaluation of clinical trials
  • Innovative trial designs
  • Interpretation of the investigator brochure
  • Clinical trial quality

INTENDED AUDIENCE

This is a clinical investigator training course targeted to all stakeholders in the clinical trial enterprise including industry, academia, and regulators (both local and foreign).The course is designed for clinical investigators, health care professionals (physicians, nurses, pharmacists, other healthcare workers), and individuals involved in biomedical research and the development of medical products.

FDA RESOURCES

CONTINUING EDUCATION

This course has been approved for 7.75 contact hours of continuing education for physicians, pharmacists, and nurses. Please see detailed announcement for more information. Each day after the course concludes, that day's attendees will receive an email with instructions and a code to claim their credit. Only participants who attend the live broadcast via Adobe Connect will receive the claim codes.

This course has been:

  • pre-approved by RAPS as eligible for a maximum of 12 credits for a two day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
  • pre-approved by SOCRA who 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.
  • pre-approved by SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.
  • approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.

TECHNICAL INFORMATION

  • To optimize your webinar experience, use Chrome when viewing AdobeConnect in a browser.
  • Please contact info@sbiaevents.com for all technical questions.
  • If you encounter any technical issues before or during the event, please visit the Technical Issues Support
  • Test your PC for use with Adobe Connect prior to the day of the event. Adobe, the Adobe logo, Acrobat and Acrobat Connect are either registered trademarks or trademarks of Adobe Systems Incorporated in the United States and/or other countries.
Back to Top