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.
European Centre for Clinical Research Training (ECCRT)
South Centre Titanium (4th floor)
Marcel Broodthaers plein 8 - 1060 Brussels, Belgium
1 500,00 € excl. VAT (if applicable)