Corsi di studio in
Farmacia - Chimica e tecnologia farmaceutiche

Provide students with the necessary knowledge in the field of regulatory affairs for categories of medicinal products, cosmetics, medical devices, biocides, food supplements and food for specific groups (FSG).

D1 - KNOWLEDGE AND UNDERSTANDING
Acquisition of specialist knowledge and skills related to the methods of preparing the registration and notification applications for products intended for health, examining the procedures for drafting and preparing documentation to obtain the various authorizations for the production and marketing of medicines, cosmetics , medical devices, biocides, food supplements and food for specific groups (FSG).

D2 - ABILITY TO APPLY KNOWLEDGE AND UNDERSTANDING
Acquisition of the ability to autonomously orientate oneself between the rules, the disciplinary regulations and the circulars within the profession even when, in the light of new knowledge and scientific evidence, guiding and / or reference parameters have not yet been defined.

D3 - AUTONOMY OF JUDGMENT
Acquisition of the ability to independently identify the discipline applicable to the knowledge of the legal characteristics regarding the composition, production, presentation and labeling, and marketing of the various health products.

D4 - COMMUNICATION SKILLS
Acquisition of the ability to express oneself clearly and with appropriate terms (in Italian and / or in English) regarding the regulatory aspects that frame health products.

D5 - LEARNING SKILLS
Acquisition of the ability to find and learn independently and linking, within the framework of the product, the alternation of new legal orientations to the pre-existing ones.

Current regulations for each category: medicinal products, foods, cosmetics, medical devices. Safety evaluation, labeling rules, public accessibility, marketing and advertising. Comparison of medicines registration procedures. Patent aspects of the medicinal products.

The course comprises 32 hours of face-to-face teaching and takes place in class following the official lesson calendar. The platform (Moodle https://elearning.unito.it/dstf/course/view.php?id=829) course includes: pdf lesson materials ; exercises to be carried out online and / or in presence; in-depth teaching materials that can be discussed in the classroom (streaming) during the lesson-debate.

The learning assessment is oral and it focuses on the preparation of a dossier that is documented from a regulatory perspective and accompanies the manufacture and marketing of one of the products from the areas of cosmetics, medical devices, food supplements and special medical foods, medicinal products. You will be asked to present the dossier in an interview using a power point presentation (ppt) in English.

The ability to search for coherent and reliable regional/national/European bibliographical sources, critical sense, communication skills, ability to tackle the problem, ability to apply knowledge and ability to make connections between different topics will be assessed, rather than the mere verification of acquired knowledge.

Teachers' Material
http://www.trovanorme.salute.gov.it/