FDA Clinical Investigator Training Course Update
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.
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
Subject matter experts will discuss scientific and operational updates.
You can review the agenda and register once for two great webinars.
DATES
Scientific Updates for Clinical Investigators
December 7, 2021
1:00 PM - 5:00 PM (Eastern)
Operational Updates for Clinical Investigators
December 8, 2021
1:00 PM - 4:30 PM (Eastern)
These webinars are FREE and have been approved for a combined 6.75 continuing education credits for pharmacists, physicians, and nurses.
