510540 - INDUSTRIALIZATION AND REGULATORY ASPECTS

The following topics will be developed:
- pharmaceutical manufacturing and GMP compliance;
- regulatory aspects.
Concerning the regulatory aspects, since the second year students during the thesis internship will start being engaged in the development of nanomedicine products, it is important that they correctly understand the regulatory definition/concept of medicinal products, intended as high value essential goods, whose quality must be assured during the entire lifecycle and whose therapeutic value must be continuously monitored by the Regulatory Bodies for the benefit of both patients and social communities.
This understanding is pivotal to correctly manage the translation from the laboratory scale formulation (driven by a given therapeutic idea) and the preclinical studies to the clinical stages and then to the final ready-to-market commercial scale product, so-called translation from bench to bedside.
The general objective of the module is to provide the students with information on the procedures to be followed to obtain the marketing authorization MA for a nanomedicine product, including the preparation of the dossier for the marketing authorization application MAA and the role of regulatory bodies in the assessment of the MAA. The student should understand the European and international regulatory scenario for MMA with special reference to the quality and to the associated risk/benefit ratio of a given medicinal product.