Regulatory Sciences and Market Access of Therapeutic and Healthcare Products: Drugs, Medical Devices, Cosmetics and Food Supplements
2nd level vocational master
A.Y. 2023/2024
Study area
Medicine and Healthcare
Master Coordinator
The vocational master?s programme is intended for graduates of science subjects who aspire to work in the various sectors of the pharmaceutical, food, cosmetics and healthcare industries. The programme aims to provide precise regulatory and practical information on medicinal and healthcare product life cycles, with a focus on the assurance of quality, efficacy and safety through obtaining and maintaining production authorisation and on the various systems for placing products on the market.
The programme includes 224 hours (27 CFUs) of face-to-face teaching and 285 hours (19 CFUs) of other training activities, 66 hours of which will take the form of e-learning. Face-to-face teaching will comprise the following units:
- Product classification
- Medical devices and in-vitro diagnostics: definitions and regulations
- Surgical devices and biocides
- Dietary supplements
- Cosmetics
- Drug regulation
- Drug registration procedures and CTDs
- Clinical trials
- Market access of drugs and medical devices
To complete the programme, students must undertake an internship of 300 hours (12 CFUs), with a final exam (2 CFUs) consisting of a review paper on a regulatory topic.
The programme includes 224 hours (27 CFUs) of face-to-face teaching and 285 hours (19 CFUs) of other training activities, 66 hours of which will take the form of e-learning. Face-to-face teaching will comprise the following units:
- Product classification
- Medical devices and in-vitro diagnostics: definitions and regulations
- Surgical devices and biocides
- Dietary supplements
- Cosmetics
- Drug regulation
- Drug registration procedures and CTDs
- Clinical trials
- Market access of drugs and medical devices
To complete the programme, students must undertake an internship of 300 hours (12 CFUs), with a final exam (2 CFUs) consisting of a review paper on a regulatory topic.
The programme is open to graduates of the following Master's degrees (Italian Ministerial Decree 270/2004): LM-6 Biology, LM-8 Industrial Biotechnology, LM-9 Medical, Veterinary and Pharmaceutical Biotechnology, LM-13 Pharmacy and Industrial Pharmacy, LM-21 Biomedical Engineering, LM-41 Medicine and Surgery, LM-42 Veterinary Medicine, LM-54 Chemical Sciences, LMG/01 Law, LM/SNT1 Nursing and Midwifery, LM/SNT2 Health Professions for Rehabilitation, LM/SNT3 Health Professions for Technical Assistance, LM/SNT4 Health Professions for Preventive Care.
The vocational master?s programme aims to train skilled professionals to work in: pharmaceutical industries, food industries, cosmetics industries; various health-related industries; consulting companies; public bodies supervising health-related products.
- Department of Pharmaceutical Sciences
[email protected]
+3902 50324639 - 42
Courses list
Open sessions
| Courses or activities | Professor(s) | ECTS | Total hours | Language |
|---|---|---|---|---|
| Compulsory | ||||
| Clinical Trials | 4 | 32 | Italian | |
| Corso dedicato a dispositivi medici e cosmetici | 2 | 36 | Italian | |
| Corso dedicato ai medicinali | 4 | 54 | Italian | |
| Cosmetics | 2 | 16 | Italian | |
| Dietary Supplements | 3 | 24 | Italian | |
| Drug Registration Procedures and Ctds | 4 | 32 | Italian | |
| Drug Regulation | 3 | 24 | Italian | |
| Esercitazione cosmetici: documentazione tecnica, portale cpnp, procedura di notifica | 2 | 30 | Italian | |
| Esercitazione dispositivi medici e i diagnostici in vitro: documentazione tecnica | 3 | 45 | Italian | |
| Esercitazione integratori alimentari: simulazione di composizione, etichettatura | 3 | 45 | Italian | |
| Esercitazione market access | 2 | 30 | Italian | |
| Esercitazione medicinali: allestimento documentazione tecnica | 3 | 45 | Italian | |
| Market Access of Drugs and Medical Devices | 2 | 20 | Italian | |
| Medical Devices and In-Vitro Diagnostics: Definitions and Regulations | 7 | 56 | Italian | |
| Product Classification | 1 | 10 | Italian | |
| Surgical Devices and Biocides | 1 | 10 | Italian | |