In this online self-paced course, you will be introduced to the concept of translational science and medicine, including topics such as target validation, predictive models, biomarkers, clinical trials and their implementation and finally intellectual property and regulatory science.
This online self-paced course consists of 4 Units representing the key challenges of the ATMPs development cycle – Scientific, Manufacturing, Reimbursement and Regulatory. Participants will have a chance to listen to talks by 12 top scientists, industry experts and regulators in the field, get acquainted with the relevant literature, and complete assignments such as developing a potency assay strategy for a new ATMP, building a submission dossier for regulatory review for a new cell therapy, and performing a Health Technology Assessment on an ATMP using the HTA Core Model.
The self-paced course features 7 learning units addressing prophylactic and cancer vaccines from the scientific and regulatory point of view. The course is designed for professionals working on vaccine development who need an introduction to the (EU) regulatory requirements associated with the field. The course covers mainly prophylactic vaccines including CMC, preclinical and Phase I-II of vaccine development, and touches on therapeutic and cancer vaccines as well, both from the scientific and regulatory point of view. The course is based on materials developed as part of the TRANSVAC project that was supported by Horizon 2020
The “PERMIT Overview” series provides a brief overview of the personalised medicine research pipeline. It gives a quick explanation of the methodology that was followed to develop the recommendations, and presents each of the stages of the personalised medicine pipeline, their challenges and how the recommendations can help to strengthen the quality of the research.