||An educational program of the NIH Clinical Center-FDA CDER Joint Task Force emphasizing regulatory requirements for clinical trials of new and repurposed drugs, with a special focus on rare diseases.
Clinical investigators, clinical research study coordinators, clinical and translational research scientists and trainees.
• To provide training in FDA regulations for NIH investigators involved in phase I and phase II clinical trials of investigational drugs, emphasizing safety considerations in the early phases of drug development.
• To describe the IND-enabling elements of non-clinical research that are required to implement a first-in-human clinical trial, including chemistry, manufacturing, and controls (CMC) conducted under good manufacturing practice (GMP) conditions, and non-clinical pharmacology and toxicology studies.
• To address special considerations applicable to drug development for rare diseases, including limited number of patients and the need for well-designed, efficient, and informative phase I-II clinical trials to support further development of novel therapies for rare diseases.
• To inform the NIH clinical research community about new web-based tools that will facilitate IND submissions.