Ateneo - UPO

EU regulatory framework and guidelines for medical devices (human use - DM) and veterinary devices (DVet).
Typologies, classification, and traceability systems of MD and DVet.
Focus on pharmacy-based device management and industrial manufacturing processes for DM and DVet.
Structure of the skin.
Raw materials, cosmetic forms, and functions.
Regulatory framework: Regulation (EC) No. 1223/2009 on cosmetic products.
Cosmetic products classified by function and body districts.
Stability testing and efficacy assessment.
Introduction to production facilities and packaging processes.
Cosmetic marketing and sales.
Artificial Intelligence in the cosmetic supply chain.
Cosmetic certifications.
Borderline cosmetics, specialized cosmetics, and nutricosmetics.
Practical laboratory exercises: preparation of cosmetic products, their quality control and labeling.

D’Agostinis G, Elio Mignini E. Manuale del cosmetologo. 2022. Tecniche nuove.
Borellini U. Manuale di cosmetologia. Scienza e tecnologie cosmetiche per i professionisti dell'estetica. 2025. Edra. (Anche ebook).
Aracri R et al. Il diritto nella cosmesi. 2023. Tecniche nuove.
Manfredini S, Vertuani S. Prodotti cosmetici a connotazione naturale e sostenibile. 2024. Piccin.
Penazzi G, Colletti A. Beautiful skin: consigli di cosmesi e nutraceutica per le persone in terapia oncologica. Edra. 2022. (Anche ebook).
Bettiol F et al. Manuale delle preparazioni veterinarie: normativa, REV, gestione dei medicinali, formulazioni galeniche tradizionali e innovative in campo veterinario. Tecniche nuove. 2025.

The theoretical component of the module is designed to provide students with the fundamental knowledge concerning two categories of health products commonly found in pharmacies, pharmaceutical dispensaries, hospitals, and on the market: medical devices (for both human and veterinary use) and cosmetic products. To this end, the lectures within the module aim to offer a comprehensive overview of the regulatory framework governing the entire lifecycle management of medical devices, as well as the regulatory and manufacturing aspects specific to the cosmetic supply chain. Concerning cosmetics, particular emphasis will be paid to the physicochemical characteristics and technological properties of ingredients, a thorough understanding of which represents an essential prerequisite for proper formulation activities of cosmetic products, including those of current interest (certified cosmetics and premium cosmetics). Preparation technologies, quality control methodologies, industrial production processes, and distribution channels will be considered as key elements for grasping the full scope of the cosmetic supply chain.
The theoretical foundations will provide the conceptual tools necessary to fully appreciate the rationale underlying the second part of the module, which is dedicated to the laboratory development of a cosmetic product, conceived as a moment of synthesis and application of the knowledge acquired.

Fundamentals of organic chemistry, pharmacology, and pharmaceutical technology.

Frontal lessons (5 CFU) are held in the classroom and are supported by multimedia tools for the projection of teaching materials. Practical exercises (1 CFU) are mandatory and carried out individually in the laboratory. Some cosmetics-related lessons and some laboratory exercises may be conducted in collaboration with cosmetic companies.

The frequency of the frontal lessons and the practical laboratory exercises is mandatory and certified by the teacher. It is not allowed to record, video record, or photograph the lessons, both frontal and in the laboratory.
Students with physical disabilities, Learning Disabilities, or Special Education Needs can request specific services and tools via the "Staff Sviluppo e Coordinamento Carriere e Servizi alle Studentesse e agli
Studenti", consulting the University webpage: https://www.uniupo.it/en/services/services-students-physical-or-learningStudents with disabilities, learning disabilities or special education needs, once they have contacted the University Staff, can refer to the tutor in charge of the course to define the examination modalities, concerning academic aspects.

The in itinere test for the "Cosmetic Products and Medical Devices" module is held at the end of the lessons and practical laboratory exercises. It assesses the student's knowledge of the regulatory foundations governing the management and classification of medical devices, for human and veterinary use, and cosmetic products, as well as their in-depth knowledge of the chemistry of cosmetic raw materials, development phases, and manufacturing and quality control processes for finished products.
The exam includes questions designed to assess the student's level of learning, ability to independently apply acquired knowledge, and communication skills, particularly the use of appropriate terminology specific to the health products sector covered in the module. The overall assessment also considers the student's ability to integrate theoretical knowledge, essential for proper product management and for verifying labeling compliance with regulatory requirements, with the operational skills developed in the laboratory. It also assesses the ability to critically consult cosmetic-technological and regulatory databases, a skill considered essential for a knowledgeable approach to both the profession of cosmetologist in the industry and that of pharmacist in the community.
The exam evaluation is valid with a minimum mark of 18/30; this mark contributes to the final grade for the entire course “Products for health and wellness”, accounting for 6 CFU out of a total of 15 CFU.

Regulatory Framework: Regulation (EU) 2017/745 on medical devices for human use (DM) and relevant national ministerial guidelines for veterinary medical devices (DVet).
Typologies and classification DM and DVet. Traceability: implementation of UDI (Unique Device Identification) systems, supply chain tracking, and post-market surveillance for both MD and DVet.
Procurement, storage, dispensing, and adverse event reporting related to medical devices within pharmacy settings.
Industrial Production of DM and DVet: overview of Good Manufacturing Practices (GMP) and quality management systems (ISO 13485).
Skin structure and appendages. Skin functions. Microbiome and microbiota. Skin absorption. Phenotype, phototype, and skin types.
Raw materials: lipids, surfactants, additives, and functional substances.
Cosmetic forms/vehicles: solutions, gels, emulsions, oleolites (oil-based dispersions), tensiolites (surfactant-based systems), anhydrous systems, sprays, and patches.
Cosmetic functions: hygienic, nourishing/conditioning, and aesthetic.
Regulatory framework: Regulation EC No. 1223/2009 on cosmetic products. INCI nomenclature, manufacturing, and safety. Product Information File (PIF) and labeling. Fragrances and allergens. Microplastics. Cosmetovigilance.
Cosmetic products for: skincare, haircare, body care, cleansing, suncare, oral care, make-up, and deodorants.
Evaluation of cosmetic product performance: safety, tolerability, efficacy, stability, and quality control.
Manufacturing and distribution cosmetic technology. Introduction to: packaging, production plants, and filling/packaging facilities.
Marketing and sales: distribution channels, cosmetic market segments, trends, brands, and cosmetic marketing strategies.
Artificial intelligence in the cosmetic supply chain: from new ingredient discovery and finished product formulation, to supply chain optimization, quality control, and personalization.
Certifications: natural, organic, and sustainable cosmetics. Formulation approaches, certification, and ISO standards. ICEA, COSMOS, NATRUE, Ecolabel, and Cradle to Cradle® certifications. Introduction to green chemistry.
Borderline cosmetic products: regulatory classification of products straddling different commercial/product categories.
Specialist cosmetics: dermocosmetics, neurocosmetics, and oncological cosmetics.
Nutricosmetics: introduction.
Practical laboratory exercises: preparation of cosmetic products for skincare, haircare, toiletries, and make-up. Quality control of finished products. Labeling.

Students must demonstrate the regulatory expertise necessary for the proper management of medical devices and cosmetic products. They must also apply the theoretical knowledge acquired and critically address technological and cosmetic issues. Therefore, they must demonstrate command of the appropriate scientific language to illustrate the chemical, physical, and technological properties of ingredients and solid, liquid, and semi-solid cosmetic formulations. They must also possess knowledge of the equipment used in both the preparation and quality control phases of various cosmetic formulations, as well as in industrial-scale production processes.