With participation of the Belgian Competent Authority
The safety of the subject in any clinical trial is of paramount consideration. First in Human 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 is not always been adequate. The gap first needs to be understood 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 both the preclinical and clinical perspective and then discussing the regulatory aspects of the development.
- The second day will focus on challenges faced and practical aspects such as pharmacovigilance and role of the QP, GMP compliance & IMP handling etc. There will also be debates and workshops to make the sessions interactive and more hands-on.
Course timeDay 1: 10h00 – 17h00 / Day 2: 08h30 – 15h00
Who should attend
- Everyone associated with First in Human studies
- Everyone 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.
- A CMC Perspective for clinical development
- Small molecule vs. Biological –
Aspects to consider moving from preclinical to clinical
- A Preclinical Perspective –
preclinical requirements to enter the clinic
- A Clinical Perspective – FIH designs
- A regulators perspective on a
1st in man human study
- FIH Clinical Trial Applications
in Europe: Challenges and Opportunities
- Pharmacovigilance: Drug safety management and reporting relating to FIH trial
- Role of the QP, GMP Compliance
& IMP Handling, to support Phase I Clinical Studies
- Workshop on assessing a preclinical file
- What CMC data do I need to have generated to allow my company to move forward into a Phase I study
- Understand the difference between small molecules and biologicals when moving from preclinical to clinical
- Understand the elements needed to set the dose for a first in human study
- Being able to identify what is an appropriate design of a first in human clinical study
- Understand regulatory aspects involved in first clinical studies
- Understand the drug safety aspects involved in a first in human trial
- Being able to assess a preclinical file for its readiness to move into clinic
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)