Regulatory Sciences and Market Access of Therapeutic and Healthcare Products: Drugs, Medical Devices, Cosmetics and Food Supplements

Master
2nd level vocational master
A.Y. 2023/2024
Study area
Medicine and Healthcare
2nd level vocational master
60
ECTS
1
Years
14-03-2024 - 14-03-2025
Italian
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 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.

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

Enrolment

Places available: 20

Call for applications

Please refer to the call for admission test dates and contents, and how to register.

Application for admission: from 02/12/2023 to 05/02/2024

Application for matriculation: from 21/02/2024 to 10/03/2024

Read the Call


Please note

Deadline for call: 5 february 2024