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Webcast | Virtual

Event Title
Clinical Investigator Training Course (CITC) Update
December 7 - 8, 2021

Scheduled

Date:
December 7 - 8, 2021
Day1:
Tue, Dec 7
Day2:
Wed, Dec 8

 

Topics & Presentations

Speakers

Clinical Investigator Training Course (CITC) Update - Scientific Updates Part 1

CITC Overview

Gene Therapy

CarT Therapy

Question and Answer Session

Leonard Sacks, MBBCh
Associate Director
Office of Medical Policy (OMP) | CDER | FDA

Lei Xu, MD, PhD
Branch Chief
General Medicine Branch II | Office of Tissues
and Advanced Therapies (OTAT)
Center for Biologics Evaluation and Research
(CBER) | FDA

Lianne Hu, MD, PhD, MPH, MS
Clinical Analyst
Division of Clinical Evaluation and
Pharmacology/Toxicology
OTAT | CBER | FDA

Peter Bross, MD
Medical Team Leader
Oncology Branch (OB) | Division of Clinical Evaluation and Pharmacology/Toxicology (DCEPT) | OTAT | CBER | FDA

Clinical Investigator Training Course (CITC) Update - Scientific Updates Part 2

Innovations in the Design of Clinical Trials in Oncology

COVID-19 Treatment

Question and Answer Session

Trial Populations – Diversity, Sex Differences, Pediatrics

Question and Answer Session

Sandra Casak, MD
Acting Team Leader, Gastrointestinal
Malignancies

Division of Oncology | Office of Oncologic
Diseases (OOD) | Office of New Drugs (OND)
CDER | FDA

Kirk Chan-Tack, MD and Sarita Boyd,
PharmD

Medical Officers
Division of Antivirals
Office of Infectious Disease (OID)
OND | CDER | FDA

Mathilda Fienkeng, PharmD, MS, RAC
CDR, USPHS
Division Director

Division of Medical Policy Development
Office of Medical Policy Initiatives (OMPI)
OMP | CDER | FDA

Kaveeta Vasisht, MD, PharmD
Associate Commissioner
Office of Women’s Health (OWH) |
Office of the Commissioner (OC) | FDA

Lynne Yao, MD
Director
Division of Pediatric and Maternal Health |
Office of Rare Diseases, Pediatrics,
Urologic and Reproductive Medicine
(ORDPURM)
OND | CDER | FDA

Clinical Investigator Training Course (CITC) Update - Operational Updates Part 1

Master Protocols

Decentralized Clinical Trials (DCTs), Digital Health

Technologies (DHTs)

Real World Evidence

Drug Repurposing

Demo Session on Portal to Submit Research Investigational New Drugs (INDs)

Question and Answer Session

Gregory Levin, PhD
Deputy Director
Division of Biometrics III | Immediate Office |
Office of Biostatistics (OB) | CDER | FDA

Leonard Sacks, MBBCh
Associate Director
OMP | CDER | FDA

John Concato, MD
Associate Director of Real-World Evidence
OMP | CDER | FDA      

Heather Stone, MPH
Public Health Analyst
OMP | CDER | FDA

Shoma Foss, MS, PMP
Senior Business Informatics Program  Manager
Office of Strategic Programs (OSP) |
Office of Business Informatics (OBI)

Clinical Investigator Training Course (CITC) Update - Operational Updates Part 2

Investigator Responsibilities

Including as Applied during

COVID-19

Question and Answer Session

Wrap Up

Cynthia Kleppinger, MD
Medical Officer
Good Clinical Practice Assessment Branch |
Division of Clinical Compliance Evaluation |
Office of Scientific Investigations (OSI) | CDER | FDA

Leonard Sacks, MBBCh
Associate Director
OMP | CDER | FDA

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)

Agenda

CDER Small Business and Industry Assistance Page

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

 

 
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