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News & Events for Human Drugs

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          News & Events for Human Drugs
          FDA Clinical Investigator Training Course (CITC) 2022 - 12/07/2022News & Events for Human Drugs Virtual
    Event Title
              FDA Clinical Investigator Training Course (CITC) 2022


                  December 7 - 8, 2022

  

    
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      Meeting InformationDate:
          
  


     
                                                       
       

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

 

  



Topics & Presentations Day 1
			SpeakersFDA Clinical Investigator Training Course (CITC) 2022, Day 1 – Part 1FDA Structure and Mandate
			**Leonard Sacks, MBBCh***Associate Director*
			Clinical Methodologies | Office of Medical Policy (OMP)
			CDER | FDAEndpoints in Cardiovascular Trials
			**Karen A. Hicks, MD., FACC***Deputy Director*
			Office of Medical Policy (OMP)
			CDER | FDASpecial 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 | FDAQ&A Session 1
			**Leonard Sacks, Karen Hicks**, and **Lynne Yao**FDA Clinical Investigator Training Course (CITC) 2022, Day 1 – Part 2Statistical Principles for Clinical Drug Development
			**Mark Levenson, PhD***Director*
			Division of Biometrics VII | CDER | FDASafety Considerations in Clinical Drug Development
			**Shabnam Naseer, DO, MMS***Medical Team Leader*
			Division of Anti-Infectives (DAI)
			Office of Infectious Diseases (OID)
			OND | CDER | FDAQ&A Session 2
			**Mark Levenson, Shabnam Naseer** and **Leonard Sacks**FDA Clinical Investigator Training Course (CITC) 2022, Day 1 – Part 3Gene 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 | FDACarT Therapy
			**Lianne Hu, MD., PhD., MPH, MS***Clinical Analyst*
			DCEPT | OTAT | CBER | FDAInternational Clinical Trials
			**Kassa Ayalew, MD., MPH***Branch Chief*
			Division of Clinical Compliance Evaluation (DCCE)
			Office of Scientific Investigations (OSI)
			CDER | FDAQ&A Session 3
			**Lei Xu, Lianne Xu, Kassa Ayalew** and **Leonard Sacks**



Topics & Presentations Day 2
			SpeakersFDA Clinical Investigator Training Course (CITC) 2022, Day 2 – Part 1Clinical 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) | FDAQ&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 | FDAInnovative Trial Designs (Decentralized Clinical Trials, Digital Health Technologies)
			**Leonard Sacks, MBBCh***Associate Director*
			Clinical Methodologies | Office of Medical Policy (OMP)
			CDER | FDAQ&A Session - 5
			**Leonard Sacks** and **John Concato**FDA Clinical Investigator Training Course (CITC) 2022, Day 2 – Part 2Chemistry, 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 | FDAPharmacology & 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 | FDAClinical 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 | FDAQ&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 qualityINTENDED 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

                                                                                  Content current as of:
      04/26/2023
         
                   
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