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.
Course timeDay 1: 09h00 – 17h00 / Day 2: 08h30 – 15h00
Who should attend
- Everyone associated with First in Human studies and/or associated with preclinical Studies.
- Project Managers & Clinical Research Associates (CRAs) working in First in Human Studies.
- Managers involved with designing First in Human studies.
- Decision makers to move from preclinical to clinical.
- Investigational sites involved in phase I research.
- Competent authorities and ECs involved in evaluating First in Human applications.
- Professionals in these fields wishing to refresh their knowledge and skills.
- Pre-Clinical Toxicology
- A CMC perspective for clinical development
- Workshop on completion of an IMPD
- Clinical Study Design
- Submission to Authorities and Ethics Committees
- A regulator’s perspective
- Maintaining quality throughout the process
- Preclinical and manufacturing towards Market Approval
- What CMC data do I need to have generated to allow my company to move forward into a Phase I study
- Describe the elements needed to set the dose for a first in human study
- Understand the content of an IMPD
- Be able to identify what an appropriate design is for a First in Human clinical study
- Define regulatory aspects involved in first clinical studies
- Understand the elements required for planning early stage clinical development
This course covers competencies that are part of the ECCRT Competency Framework:
- Scientific Concepts & Research Design (2)
- Ethical & Participants Safety Considerations (2)
- Investigational Product Development and Regulation (5)
- Clinical Studies Operations (GCPs or ISO 14155) (5)
- Study and Site Management (2)
- Data Management and Informatics (0)
- Leadership and Professionalism (0)
- Communication (0)
- Teamwork (0)
- Business acumen (0)
Be aware that attending one of ECCRT open course does not guarantee that the competency is acquired but only guarantees that the related knowledge has been trained