Conference | Virtual

Event Title

FDA Clinical Investigator Training Course (CITC) 2023

December 6 - 7, 2023

Date:: December 6 - 7, 2023
Day1:: Wed, Dec 6 11:00 AM - 4:30 PM ET
Day2:: Thu, Dec 7 11:00 AM - 4:00 PM ET

Topics & Presentations Day 1	Speakers
FDA Clinical Investigator Training Course (CITC) 2023 – Day 1 – Part 1
FDA Structure and Mandate.pdf	Kimberly Smith, MD, MS CAPT \| United States Public Health Service Real World Evidence Analytics Office of Medical Policy (OMP) CDER \| FDA
Basics of Clinical Trial Design – Design, Population, Intervention, Outcomes.pdf	Fortunato Fred Senatore, MD, PhD, FACC Lead Physician Division of Cardiology and Nephrology (DCN) Office of Cardiology, Hematology, Endocrinology and Nephrology (OCHEN) Office of New Drugs (OND) \| CDER \| FDA
New Trends in Trial Design – Decentralized Clinical Trials (DCT), Digital Health Technologies (DHT).pdf Real-World Evidence (RWE).pdf	Leonard Sacks, MBBCh Associate Director for Clinical Methodologies OMP \| CDER \| FDA John Concato, MD Associate Director of Real-World Evidence OMP \| CDER \| FDA
Q&A Discussion Panel	Kimberly Smith, Fred Senatore, Leonard Sacks, and John Concato
FDA Clinical Investigator Training Course (CITC) 2023 – Day 1 – Part 2
Trial Design Considerations in Rare Diseases.pdf	Scott Winiecki, MD Lead Physician Rare Diseases Team (RDT) Division of Rare Diseases and Medical Genetics (DRDMG) Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine (ORDPURM) OND \| CDER \| FDA
Special Populations in Clinical Trials.pdf	Lynne Yao, MD Director Division of Pediatric and Maternal Health (DPMH) ORDPURM \| OND \| CDER \| FDA
Q&A Discussion Panel	Leonard Sacks, Scott Winiecki and Lynne Yao
FDA Clinical Investigator Training Course (CITC) 2023 – Day 1 – Part 3
Safety Considerations in Clinical Drug Development.pdf	Shabnam Naseer, DO, MMS Medical Team Leader Division of Anti-Infectives (DAI) Office of Infectious Diseases (OID) OND \| CDER \| FDA
Statistical Principles for Clinical Drug Development.pdf	Mark Levenson, PhD Director Division of Biometrics VII (DBVII) Office of Biostatistics (OB) Office of Translational Sciences (OTS) CDER \| FDA
Q&A Discussion Panel	Shabnam Naseer and Mark Levenson
Day One Closing	Leonard Sacks

Topics & Presentations Day 2	Speakers
FDA Clinical Investigator Training Course (CITC) 2023 – Day 2 – Part 1
Chemistry, Manufacturing, and Controls.pdf	Paresma Patel, PhD Director Division of New Drug API (DNDAPI) Office of New Drug Products (ONDP) Office of Pharmaceutical Quality (OPQ) \| CDER
Pharmacology & Toxicology.pdf	Matthew Thompson, PhD, MPH Supervisory Pharmacologist Division of Hematology Oncology Toxicology (DHOT) Office of Oncologic Diseases (OOD) Office of New Drugs (OND) \| CDER \| FDA
Clinical Pharmacology.pdf	Shirley K. Seo, PhD Director Division of Cardiometabolic and Endocrine Pharmacology (DCEP) Office of Clinical Pharmacology (OCP) Office of Translational Sciences (OTS) \| CDER \| FDA
Q&A Discussion Panel	Leonard Sacks, Paresma Patel, Matthew Thompson and Shirley K. Seo
FDA Clinical Investigator Training Course (CITC) 2023 – Day 2 – Part 2
Investigator Responsibilities - Regulation and Clinical Trials and Clinical Trial Quality.pdf	Ann Meeker-O’Connell, MS Director Office of Clinical Policy (OCLiP) Office of Clinical Policy and Programs (OCPP) Office of the Commissioner (OC) \| FDA
Clinical Investigator Site Inspections – What to Expect.pdf	Stephanie F. Coquia, MD Good Clinical Practice Assessment Branch (GCPAB), Team 1 Division of Clinical Compliance Evaluation (DCCE) Office of Scientific Investigations (OSI) Office of Compliance (OC) \| CDER \| FDA
International Clinical Studies.pdf	Kassa Ayalew, MD, MPH Branch Chief Division of Clinical Compliance Evaluation (DCCE) OSI \| CDER \| FDA
Q&A Discussion Panel	Ann Meeker-O’Connell, Stephanie F. Coquia, and Kassa Ayalew
Wrap Up and Thank You	Leonard Sacks, MBBCh Associate Director for Clinical Methodologies OMP \| CDER \| FDA

AGENDA

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ABOUT THIS EVENT

This course is designed to promote professionalism in the clinical trial industry for individuals involved with submissions to FDA (Investigational New Drug (IND) application, New Drug Application (NDA), Biologics License Application (BLA)), and to familiarize stakeholders with the regulatory and scientific issues involved in the development and approval of medical drugs and biological products. Participants will acquire a practical understanding of:

FDA’s approach to trial design
Safety concerns in the development of medical products
Statistical issues in the analysis of trial data
Clinical investigator responsibilities

INTENDED AUDIENCE

This is a clinical investigator training course targeted at all stakeholders in the clinical trial enterprise including industry, academia, and regulators (both local and foreign). The agenda is designed for:

Clinical investigators
Health care professionals (physicians, nurses, pharmacists, other healthcare workers), and
Individuals involved in biomedical research and the development of drugs and biological products.

TOPICS COVERED

Design and conduct of clinical trials
Innovative trial designs
Considerations for rare disease drug development
Enhancing diversity in clinical trials
Addressing specific populations in drug development
Statistical evaluation of clinical trials
Understanding the investigator brochure
Clinical trial quality

U.S. Food and Drug Administration

Event Title

FDA Clinical Investigator Training Course (CITC) 2023

December 6 - 7, 2023

ABOUT THIS EVENT

INTENDED AUDIENCE

TOPICS COVERED

FDA RESOURCES

Session Recordings: