Ateneo - UPO

This course focuses on the main issues regarding regulations and the distinction between the pharmaceutical, the medical device and the cosmetic world, in Europe.

Notes and handouts distributed during seminars, websites of the regulatory agencies or of the
legislative bodies (e.g., www.ema.europa.eu; www.fda.gov; www.ich.gov).

The aim of the course is to give an overview of the requirements for cosmetics, medical devices and medicinal products to enter national or global markets and to highlight the strong differences between them.

None

Seminars

Students with physical disabilities, Learning Disabilities (LD) or Special Education Needs (SEN) 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-learning-disabilities.
Students with disabilities, LD or SEN, 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 exam is composed of two parts, each worth 50% of the final mark:
(a) 30 multiple-choice questions that will cover lectures, seminars and reading material. One point will be obtained for the correct answer, whereas wrong or blank answers will be evaluated 0 points; the exam will be on paper;
(b) a paper that will evaluate the students’ ability to apply the general knowledge shared at lectures and seminars in their own regional domains. Utilizing a specific format, students will briefly describe the regulatory framework in their own country related to cosmetics, medical devices or medicinal products. Each student may adapt the content of the paper to the specific situation of the country.
Partner country extra-UE students should describe the process that leads to medicinal product approval, the characteristics of their regulatory agency and framework, or the regulations that govern the entrance of cosmetics or medical devices on the market.
European students should describe how medicinal products are evaluated in their own country after EMA approval, as reimbursed by health systems, by insurances or by private citizens. If they wish, they may also choose a particular cosmetic product or medical device and describe the peculiarities of that product compared to the entire cosmetic or medical devices regulation, but the paper should not cover the general European cosmetic or medical devices regulation. Evaluation will be done on quality of the information, on references, on ability to answer at scheme provided, and on Turnitin report. Turnitin report is mandatory.
The two scores will be averaged.

Cosmetic regulation
· General principles that govern cosmetic regulation and substantial differences compared to pharmaceutical and medical devices regulations
· Short introduction on EU legislation
· The safety of consumer: a pillar of cosmetic legislation from the Directive 76/768/EEC to the Regulation 1223/2009
· Definition of cosmetic product and borderline products
· Roles and responsibilities along the supply chain
· Main regulatory mechanisms to address consumer safety: prohibited, restricted and authorized substances, special rules for CMR substances, nanomaterials, traces of prohibited substances, product information file, cosmetic product safety assessment, safety assessor, labelling of cosmetic products
· Cosmetic Products Notification Portal (CPNP) and notification of cosmetic products
· Cosmetic products claims and regulation 655/2013 on common criteria
· Global strategies to access the market and case studies
· The impact of EU chemical legislations, REACH and CLP, on the discipline of cosmetic ingredients
Medical device regulation
Risk Management System:
- Quality and Compliance
- UNE-EN ISO 13485:2016
- Risk Management System
Classification of the medical devices:
- What is a medical device?
- New EU Regulation
- Characteristics of the medical devices
- Classification of medical devices
- Notified bodies.
Both sessions have a theoretical and a practical part.
Pharmaceutical regulation
· Main pillars on which drug approval is based and main regulatory bodies
· The importance of regulatory affairs for successful medicinal products on the market, differences between approval and access
· Overview of the most important regulatory pathways and differences in ICH and non-ICH countries
· Designing appropriate regulatory strategies
· General overview on GLP, GCP and GMP regulations
· The medicinal product life cycle from a regulatory perspective
· Case studies

Students should be able to:
· Navigate through guidelines, regulations and laws to design adequate strategies for cosmetics, medical devices and medicinal products;
· Should be aware of the presence of guidelines for particular activities.