The safety of the subject in any clinical trial is of paramount consideration. First in Human (FIH) studies are special in this case as no data is available on how the investigational product will react in the human body. Preclinical data needs to be adequate to allow translation into a clinical study complying with all medical, scientific, ethical and regulatory aspects. Historical cases have shown that bridging preclinical and clinical has not always been adequate. The gap needs to be understood first and then strategies need to be developed to enable a smooth translation of the preclinical data of “research in animals” to the clinical research with First in Human studies.
This 2-day course highlights the various considerations to be taken into account while moving from the preclinical research to the clinical development in humans. It enables a bidirectional transfer of the knowledge and research, making the transition into clinical research smooth and effective. The first day of the course will be spent describing the preclinical perspective (toxicology and manufacturing) including a workshop on completion of an IMPD. The second day will focus on the clinical side of development, including First in Human study design, submission to authorities, the regulator’s perspective and maintaining quality throughout the process. You will be able to put your newly gained knowledge immediately into practice as the trainers will guide you to take a new compound through the entire process.