FDA Clinical Investigator Training Course (CITC) 2024 December 10 - 12, 2024

Conference | Virtual

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• Date: December 10 - 12, 2024
• Day1: Tue, Dec 10 11:00 a.m. - 03:30 p.m. ET
• Day2: Wed, Dec 11 11:00 a.m. - 04:00 p.m. ET
• Day3: Thu, Dec 12 11:00 a.m. - 03:05 p.m. ET

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Topics & Presentations Day 1	Speakers
FDA Clinical Investigator Training Course (CITC) 2024 – Day One – Session One
Welcome and Introduction	Leonard Sacks, MBBCh Associate Director for Clinical Methodologies Office of Medical Policy (OMP) CDER | FDA
FDA Structure and Mandate	Kimberly Smith, MD, MS Captain, United States Public Health Service Senior Medical Advisor OMP | CDER | FDA
Basics of Clinical Design	James P. Smith, MD, MS Director Office of New Drug Policy (ONDP) Office of New Drugs (OND) CDER | FDA
Statistical Principles for Clinical Development	Mark Levenson, PhD Acting Deputy Director Office of Biostatistics (OB) Office of Translational Sciences (OTS) CDER | FDA
Q&A Discussion Panel	Kimberly Smith (moderator), James P. Smith, and Mark Levenson
FDA Clinical Investigator Training Course (CITC) 2024 – Day One – Session Two
Safety Considerations in Clinical Drug Development	Shabnam Naseer, DO, MMS Lead Physician Division of Anti-Infectives (DAI) Office of Infectious Diseases (OID) OND | CDER | FDA
Specific Populations in Clinical Trials	Lynne Yao, MD Director Division of Pediatrics and Maternal Health (DPMH) Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine (ORPURM) OND | CDER | FDA
Q&A Discussion Panel	Leonard Sacks (Moderator), Shabnam Naseer, and Lynne Yao

Topics & Presentations Day 2	Speakers
FDA Clinical Investigator Training Course (CITC) 2024 – Day Two – Session One
Chemistry, Manufacturing and Controls: Regulatory Considerations Through Clinical Development	Paresma Patel, PhD Director Division of Product Quality Assessment XIX (DPQAXIX) Office of Product Quality Assessment (OPQA) III Office of Pharmaceutical Quality (OPQ) CDER | FDA
Pharmacology & Toxicology in the Investigator's Brochure	Nikolett Biel, PhD Senior Biologist Division of Hematology Oncology Toxicology (DHOT) Office of Oncologic Diseases (OOD) OND | CDER | FDA
Clinical Pharmacology: Early Drug Development	Shirley K. Seo, PhD Director Division of Cardiometabolic and Endocrine Pharmacology (DCEP) Office of Clinical Pharmacology (OCP) OTS | CDER | FDA
Q&A Discussion Panel	Leonard Sacks (Moderator), Paresma Patel, Nikolett Biel, and Shirley K. Seo
FDA Clinical Investigator Training Course (CITC) 2024 – Day Two – Session Two
Innovative Approaches to Clinical Trials	Leonard Sacks
Informed Consent: More than just a document	Ann Meeker-O'Connell, MS Director Office of Clinical Policy (OCP) Office of the Chief Medical Officer (OCMO) Office of the Commissioner (OC) | FDA
Q&A Discussion Panel 1	(Moderator) Mili Duggal Health Science Policy Analyst OMP | CDER | FDA And Leonard Sacks, Ann Meeker-O’Connell
mRNA Vaccines	Karin Bok, MS, PhD Deputy Director Office of Vaccines Research & Review (OVRR) Center for Biologics Evaluation and Research (CBER) | FDA
Innovative Therapeutics: Gene Therapy	Nicole Verdun, MD Super Office Director Office of Therapeutic Products (OTP) CBER | FDA
Q&A Discussion Panel 2	Leonard Sacks (Moderator), Karin Bok, and Nicole Verdun

Topics & Presentations Day 3	Speakers
FDA Clinical Investigator Training Course (CITC) 2024 – Day Three – Session One
Achieving Fit-for-Purpose Clinical Trial Quality	Cheryl Grandinetti, PharmD Associate Director for Clinical Policy Division of Clinical Compliance Evaluation (DCCE) Office of Scientific Investigations (OSI) Office of Compliance (OC) CDER | FDA
Investigator Responsibilities - Regulation and FDA Expectations for the Conduct of Clinical Trials	Miah Jung, PharmD, MS Senior Pharmacologist Division of Enforcement and Post-marketing Safety (DEPS) OSI | OC | CDER | FDA
International Clinical Trials	Kassa Ayalew, MD, MPH Division Director DCCE | OSI | OC | CDER | FDA
Q&A Discussion Panel	Leonard Sacks (Moderator), Cheryl Grandinetti, Miah Jung, and Kassa Ayalew
FDA Clinical Investigator Training Course (CITC) 2024 – Day Three – Session Two
FDA's Good Clinical Practice Compliance Review for NDAs and BLAs	Cara Alfaro, PharmD Senior Pharmacologist DCCE | OSI | OC | CDER | FDA
Clinical Investigator Inspection Readiness	Michelle Anantha, MSPAS, PA-C, RAC Senior Pharmacologist DCCE | OSI | OC | CDER | FDA
FDA’s Use of Alternative Approaches to Evaluate GCP Compliance	Emily Gebbia, JD Associate Director for Regulatory Development OSI | OC | CDER | FDA
Q&A Discussion Panel	Kimberly Smith (Moderator), Cara Alfaro, Michelle Anantha, and Emily Gebbia
Closing Remarks	Leonard Sacks

AGENDA

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ABOUT THIS EVENT (Hosted by CDER SBIA)

The primary goal of this clinical investigator training course is to provide participants with the essential knowledge and skills to conduct clinical trials effectively, ethically, and in accordance with regulatory standards. The course aims to prepare clinical investigators to conduct high-quality research that contributes to scientific knowledge and improves patient care.

Participants will acquire a practical understanding of:

• FDA’s approach to trial design
• Statistical issues in the analysis of trial data
• Safety concerns in the development of medical products
• Understanding preclinical information relevant to medical product development
• Clinical investigator responsibilities

INTENDED AUDIENCE

This clinical investigator training course is intended for all stakeholders in the clinical trial enterprise including industry, academia, and regulators (both domestic 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

• Study design and protocol development
• Biostatistics and data analysis
• Ethical considerations
• Safety considerations for clinical trials
• Data management and integrity
• Regulatory requirements and compliance
• Innovations in trial design and implementation

LEARNING OBJECTIVES

• Understand key considerations for the design of clinical trials
• Review statistical concepts relevant to the analysis and interpretation of clinical trial data
• Explain the responsibilities of clinical investigators in the conduct of clinical trials
• Understand FDA regulatory requirements and guidance related to the design and conduct of clinical trials

FDA RESOURCES

• FDA Guidances
• FDA Office of Scientific Investigations
• CDER SBIA Learn

The detailed announcement can be found at this link: U.S. Food & Drug Administration