The aim of the module is to provide the students that start being engaged in the core disciplines of Medicinal Chemistry, Pharmaceutical Technology, Biopharmacy, Pharmacology and Toxicology with basic information on the procedures to be followed to obtain the marketing authorization for a given medicinal. Having an early exposure to these rules and to the underlying rationale is fundamental to understand that medicinals are peculiar goods and that their benefit /risk balance must be rigorously checked before entering the market and monitored throughout the entire lifecycle.
Course Prerequisites
Understanding the concept of medicinal, intended as a high value essential goods, whose quality must be assured during the entire lifecycle and whose therapeutic value monitored in continue by the Regulatory Bodies for the benefit of both patients and communities.
Teaching Methods
Lectures are foreseen on the legislation, the regulatory agencies and the procedures (2 ECTS). Practicals consist in navigating on and downloading from the irrelevant wefsite (1 ECTS). Seminar on dedicated themes are also foreseen as well as guided visits to pharmaceutical companies such as Pharmacovigilance and the Distribution of Medicinals.
Assessment Methods
Self-evaluation tests based on multiple choice questions. Final written exam with both open and multiple choice questions
Texts
Directive 2001/83(82)/EC (Communitary Code for Medicinals for Human Use). Directive2003/63/CE. Decreto legislativo 24 aprile 2006 n. 219. Sitography: http://ec.europa.eu/health/index_en.htm http://www.ema.europa.eu/ http://www.edqm.eu/en/Homepage-628.html http://www.ministerosalute.it http://www.agenziafarmaco.it http://www.ich.org
Contents
The following items will be dealt with: the basics of European pharmaceutical legislation, the main european, national and international regulatory bodies and their mission and functions, the national and European procedures for the Marketing authorization applications (MMA). The informative package: Summary of product characteristics, package leaflet and labelling, the registration dossier, the CTD format, the module 3,4,5 and their contents with special emphasis on module 3 sections. Basics of pharmacovigilance, Basics of Good Manufacturing, Laboratory and Clinical Practices.
