FDA Clinical Investigator Training Course (CITC) 2023 December 6 - 7, 2023

Conference | Virtual

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• Date: December 6 - 7, 2023
• Day1: Wed, Dec 06 11:00 a.m. - 04:30 p.m. ET
• Day2: Thu, Dec 07 11:00 a.m. - 04:00 p.m. 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

FDA RESOURCES

• Draft Guidance: Digital Health Technologies for Remote Data Acquisition in Clinical Investigations
• Final Guidance: Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products

Session Recordings:

• Day One YouTube Livestream Recording
• Day Two YouTube Livestream Recording