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DATES

Scientific Updates for Clinical Investigators
December 7, 2021
1:00 PM - 5:00 PM (Eastern, UTC-5)

Operational Updates for Clinical Investigators
December 8, 2021
1:00 PM - 4:30 PM (Eastern, UTC-5)

Register Once for Two Great Webinars

Agenda

CDER Small Business and Industry Assistance Page

These webinars are FREE and have been approved for a combined 6.75 continuing education credits for pharmacists, physicians, and nurses. Please see detailed announcement for additional information. Real-time attendance is required.

Organizers note: The U.S. Food and Drug Administration’s Clinical Investigator Training Course (CITC) has been conducted in person for more than ten years. Unfortunately, due to the pandemic, it was postponed in 2020.

Given ongoing concerns about COVID-19, this year will be an abbreviated, virtual update rather than a full course.  We are hopeful that the full course will resume in 2022.


TOPICS

• Gene Therapy and CarT Therapy
• Medical Products for the Prevention and Treatment of COVID-19
• Emergency Use Authorizations for COVID-19
• Trial Approaches including Master Protocols, Decentralized Clinical Trials, Digital Health Technologies, and use of Real-World Data/Evidence
• Drug Repurposing
• Diverse Representation in Clinical Trials
• Investigator Responsibilities including as applied during COVID-19

WHO SHOULD ATTEND?

To maximize the value of this update, we recommend attendees possess a basic understanding of clinical trials, regulatory requirements for conducting those trials, and medical product development. The following are some categories of professionals who may benefit the most from the update:

• Healthcare professionals (physicians, nurses, and pharmacists, clinical scientists)
• Consultants
• Drug, device, and biologic industry employees
• Regulatory affairs professionals
• Biomedical professionals

LEARNING OBJECTIVES

• Explain the scientific and regulatory challenges related to gene therapy and Cart therapy
• Review the development of medical products for the prevention and treatment of Covid-19
• Describe the responsibilities of an investigator conducting a clinical trial
• Describe innovative approaches to the conduct of clinical trials

CONTINUING EDUCATION

Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event.

This course has been:

• pre-approved by RAPS as eligible for a maximum of 12 credits for a 2 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 [email protected] 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.