ADVANCE Webinar – Regulatory and Clinical aspects of ATMPsJoin event
|Date & Time||May 28, 2020|
ADVANCE is an innovative and focused learning programme for future advanced therapies’ developers. This is the first scientific webinar in the ADVANCE Webinar series and will focus on the regulatory and clinical aspects of ATMPs development. The regulatory framework for advanced therapy medicinal products (ATMPs) is designed to ensure safe patient access to these medicines within the European Union (EU). Several European regulations, directives and guidences, as well as national laws and guidelines, are applicable in the ATMP field, targeting diverse types of ATMPs and aspects of the development pathway. This webinar will provide an overview of the ATMP regulatory framework as well as a concrete practical example of cells and tissue applications to demonstrate the impact of the ATMP regulatory framework in clinical reality.
Prof. dr. Isabelle Huys is pharmacist by training and with PhD in pharmaceutical sciences (toxicology) and further specialisation in regulations on medicinal product development at KU Leuven, including intellectual property rights.
Her research focusses on access to medicines and therapies. The research program studies diverse legal and regulatory aspects along the continuum of a medicinal product life cycle, from medicinal product discovery, development, approval, reimbursement and market adoption. The research program focuses on all types of medicinal products (small molecules, biologicals, advanced therapy medicinal products (ATMPs)) and diagnostics. Topics include biobanking and access to (human) biological samples and data, the use of real-world data/evidence (RWE) in medicinal product development and market access, repurposing of medicines for other (e.g. cancer) indications, patient preferences in medicinal product development and evaluation, precision medicine and companion diagnostics, off-patent strategies of biological products and market access of biosimilar and drug shortages. Isabelle Huys actively participated in several collaborative projects, bilateral university-industry, university-non-profit organisations, public-private partnerships of large scale (e.g. IMI, H2020, ERASMUS+, Marie-Curie ITN). Isabelle Huys supervises PhD projects in this research program and publishes the research in diverse journals.
Dr. Gilbert Verbeken studied at the Ghent University, the KU Leuven and the Royal Military Academy (Belgium). As a (biomedical) biologist, he is more than 30 years active in the field of human cell- and tissue-engineering and human cell- and tissue-banking. Gilbert built up, among other things, significant “Advanced Therapy Medicinal Products” (ATMP) regulatory experience. He is also involved in the creation of a Bacteriophage Therapy Centre at the Queen Astrid Military Hospital, Brussels, Belgium. He obtained his PhD degrees studying the regulatory hurdles and ethical issues related to the (re-) introduction of (natural) bacteriophage therapy into Europe. Gilbert is appointed expert-advisor to the Belgian Superior Health Council (since 2007). He is engaged in several National, EU and NATO task groups and advisory committees. Gilbert was (part-time) (volunteer) scientific co-operator at the Free University of Brussels (2007-2017). He still is (part-time) (volunteer) scientific co-operator at the KU Leuven and the Belgian Royal Military Academy.