Course Overview
This course discusses the key regulatory requirements and issues surrounding developing and translating an advanced therapeutic medicinal product (ATMP) to the clinical trial and market authorisation application.
ATMPs represent a growing number of therapeutics entering clinical development and market authorisation application (MAA). This cutting edge therapeutic area sits with an evolving area of legislation. During this one day course you will be introduced to ATMPs and their categories, key factors to consider with your process development from bench to clinic including Good manufacturing Practices (GMP), preparation and submission of Investigative Medicinal Product Dossiers (IMPD) and Investigator Brochures (IB), quality, potency and stability assessment of your product.
