FDA Clinical Investigator Training Course (CITC) 2022 December 7 - 8, 2022

Virtual | Virtual

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• Date: December 7 - 8, 2022
• Day1: Wed, Dec 7 11:00 AM - 3:35 PM ET
• Day2: Thu, Dec 8 10:55 AM - 2:40 PM ET

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Topics & Presentations Day 1	Speakers
FDA Clinical Investigator Training Course (CITC) 2022, Day 1 – Part 1
FDA Structure and Mandate	Leonard Sacks, MBBCh Associate Director Clinical Methodologies | Office of Medical Policy (OMP) CDER | FDA
Endpoints in Cardiovascular Trials	Karen A. Hicks, MD., FACC Deputy Director Office of Medical Policy (OMP) CDER | FDA
Special Populations in Clinical Trials	Lynne Yao, MD Director Division of Pediatric and Maternal Health (DPMH) Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine (ORDPURM) Office of New Drugs (OND) | CDER | FDA
Q&A Session 1	Leonard Sacks, Karen Hicks, and Lynne Yao
FDA Clinical Investigator Training Course (CITC) 2022, Day 1 – Part 2
Statistical Principles for Clinical Drug Development	Mark Levenson, PhD Director Division of Biometrics VII | CDER | FDA
Safety Considerations in Clinical Drug Development	Shabnam Naseer, DO, MMS Medical Team Leader Division of Anti-Infectives (DAI) Office of Infectious Diseases (OID) OND | CDER | FDA
Q&A Session 2	Mark Levenson, Shabnam Naseer and Leonard Sacks
FDA Clinical Investigator Training Course (CITC) 2022, Day 1 – Part 3
Gene Therapy	Lei Xu, MD., PhD Branch Chief General Medicine Brach 2 (GMB2) Division of Clinical Evaluation & Pharmacology/Toxicology (DCEPT) Office of Tissues and Advanced Therapies (OTAT) | CBER | FDA
CarT Therapy	Lianne Hu, MD., PhD., MPH, MS Clinical Analyst DCEPT | OTAT | CBER | FDA
International Clinical Trials	Kassa Ayalew, MD., MPH Branch Chief Division of Clinical Compliance Evaluation (DCCE) Office of Scientific Investigations (OSI) CDER | FDA
Q&A Session 3	Lei Xu, Lianne Xu, Kassa Ayalew and Leonard Sacks

 

Topics & Presentations Day 2	Speakers
FDA Clinical Investigator Training Course (CITC) 2022, Day 2 – Part 1
Clinical Trial Quality	Ann Meeker-O’Connell, MS Director Office of Clinical Policy (OCLiP) Office of Clinical Policy and Programs (OCPP) Office of the Commissioner (OC) | FDA
Q&A Session - 4	Leonard Sacks and Ann Meeker-O’Connell
Real World Evidence	John Concato, MD Associate Director of Real-World Evidence Office of Medical Policy (OMP) | CDER | FDA
Innovative Trial Designs (Decentralized Clinical Trials, Digital Health Technologies)	Leonard Sacks, MBBCh Associate Director Clinical Methodologies | Office of Medical Policy (OMP) CDER | FDA
Q&A Session - 5	Leonard Sacks and John Concato
FDA Clinical Investigator Training Course (CITC) 2022, Day 2 – Part 2
Chemistry, Manufacturing, and Controls: Requirements for Early Clinical Development	Paresma Patel, PhD Division Director Division of New Drug API Office of New Drug Products (ONDP) Office of Pharmaceutical Quality (OPQ) | CDER | FDA
Pharmacology & Toxicology Information to Support Early Drug Development	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: Early Drug Development	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 Session 6	Leonard Sacks, Paresma Patel, Matthew Thompson, and Shirley Seo
Day Two Closing	Leonard Sacks, MBBCh Associate Director Office of Medical Policy (OMP) | CDER | FDA

Agenda

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ABOUT THIS CONFERENCE

This course is designed to promote professionalism in the clinical trial industry for individuals involved with FDA submissions (Investigational New Drug (IND) Application, New Drug Application (NDA), Biologic License Application (BLA), and Investigational Device Exemption (IDE)), and to familiarize stakeholders with the regulatory and scientific issues involved in the development and approval of medical products. Participants will acquire a practical understanding of FDA’s approach to the evaluation of clinical trials, associated regulatory requirements, and other scientific issues related to investigational medical products.

TOPICS COVERED

• Design and conduct of clinical trials
• Determining appropriate endpoints in clinical trials
• Efforts to advance diversity in trial populations
• Statistical evaluation of clinical trials
• Innovative trial designs
• Interpretation of the investigator brochure
• Clinical trial quality

INTENDED AUDIENCE

This is a clinical investigator training course targeted to all stakeholders in the clinical trial enterprise including industry, academia, and regulators (both local and foreign).The course is designed for clinical investigators, health care professionals (physicians, nurses, pharmacists, other healthcare workers), and individuals involved in biomedical research and the development of medical products.

FDA RESOURCES

• Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biologic Products Guidance for Industry – Draft Guidance
• Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biologic Products – Draft Guidance
• Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products
• Digital Health Technologies for Remote Data Acquisition in Clinical Investigations – Draft Guidance