FDA Clinical Investigator Training Course (CITC) 2024 - Promo Video

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

Clinical Pharmacology Considerations for Novel Therapeutic Modalities - Webinar

This webinar will discuss the clinical pharmacology considerations for the development of novel therapeutic modalities. Our FDA subject matter experts will also address the unique considerations for oligonucleotide therapeutics and antibody-drug conjugates with respect to topics such as dose selection, exposure/response analysis, organ impairment, drug interactions, QTc assessment, and immunogenicity. 

M13A: Bioequivalence for Immediate-Release Solid Oral Dosage Forms -- Implementing the Final Guidance - Webinar

This webinar will provide an update and overview on the final M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms guideline including major changes from the draft guideline and FDA’s current bioequivalence (BE) guidance, delineate FDA’s planning on the implementation of M13A, and address questions and provide clarifications based on questions/comments received during public consultation of the draft guideline.

FDA Clinical Investigator Training Course (CITC) 2024

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.