|SCIENTIFIC DISCIPLINARY SECTOR||CHIM/09|
The preliminary evaluation of quality, efficacy and safety of biologically active substances, medicines and medical devices implies the technical knowledge of several national and international rules regulating the world of health products. The Regulatory Affairs is a key area in the contemporary organization of the pharmaceutical and medical devices industry, hiring many graduates in scientific disciplines with a solid preparation in the technical-regulatory aspects regulating this important industrial area.
This class has the objective of introducing the regulatory classification of medicines and medical devices, also defining the commercial marketing value and outlining the authorization processes allowing the industrial production and the marketing of these products, with particular attention to the European regulation.
The organization and roles in the definition of the guide-lines regulating these important areas of the most important Regulatory Agencies (like EMA, AIFA and FDA) and of other institutions involved (like the Health Ministry, ISS, EDQM, WHO and ICH), will be described.
The educational objectives of the course are: to classify and compare, from the regulatory point of view, medicines and medical devices; to provide a basic knowledge of the rules regulating the production, control, surveillance and marketing of the biologically active substances and of the deriving medicines; to define the role and authority of the regulatory institutions involved.
The objectives of the course are: to present the regulatory classification of products of biotechnological interest: medicines, medical devices and in vitro diagnostics; to provide a basic knowledge of the rules regulating the production, control, marketing and surveillance of the biologically active substances and medicines, for both human and veterinary use, mainly at the European level but also including some hints regarding the legislation of the extra-EU area; to study the different procedures for the marketing authorization (national, DCP, MR, centralized); to provide a basic knowledge of the rules regulating the production, control, marketing and surveillance of the medical devices and of the medical devices for in vitro diagnostics, distinguished by the risk class; to mention some aspects related to the national legislation (CND legislation); to describe the structure and the functions of the regulatory institutions involved (Health Ministry, ISS, AIFA at the national level; EMA, EDQM, WHO, ICH at the international level). At the end of the course, the student should possess the basic knowledge of the legislation regarding the biotechnological products and should be able to state their differences.
It is suggested to be aware of the main production techniques to obtain biotechnological products.
The course includes 16 hours of frontal lesson, with the support of the didactic material provided to the students through Aulaweb.
The attendance to the lessons and the material provided on Aulaweb are sufficient to prepare the final exam. For any further detailed-study, the recommended texts are the following:
Office hours: The teacher receives the students by appointment agreed through the institutional mail address available on the University website.
All class schedules are posted on the EasyAcademy portal.
The exam involves passing a written test composed of multiple-choice questions.
The exam evaluates the knowledge of the main rules regulating the production and marketing of medicines and medical devices of biotechnological origin.