GENERAL PRINCIPLES OF DRUG AND COSMETIC REGULATION

Silvia Morel (12 h – 2 ECTS)

After a PhD in Chemistry of Drugs and a Post-Doc at the University of Turin, she became Assistant Professor at the Department of Drug Science and Technology (University of Turin). At present, she is Associate Professor of Pharmaceutical Technology at the Department of Pharmaceutical Sciences (UPO). Her interests include biocompatible colloidal systems, semi-solid preparations for pharmaceutical and cosmetic use and Italian and European legislation on medicinal and healthy products.

Academic lecturers: 0

Guest lecturers: 12

Laboratory: 0

Armando Genazzani (6 h – 1 ECTS)

Armando Genazzani obtained his degree in Medicine and Surgery in 1992. He then moved to Oxford, to the Eidgenössische Technische Hochschule (ETH, Zurich; where he held an EMBO long-term fellowship) and to Cambridge, where he was appointed to a lectureship up to retirement age and was also named an Official Fellow and graduate tutor of Clare Hall.He returned to Italy in 2003 and is now a Full Professor of Pharmacology.

He has authored over 150 papers in international journals and is a named inventor on four patents in the field that have been licenced or have been the object of research contracts with pharmaceutical companies. He has also received the David Phillips Fellowship for research in marine biology and the Marine Biology station of Plymouth in 1997 and the Galeno Prize for Young Scientists in 2008.

At present he organizes a Masters degree in Regulatory Affairs and Market Access, is the Vice-Rector of the University for International Relations and is on the expert panel of the World Health Organization for international non-proprietary names. He has sat on the Scientific-Technical Committee of the Italian Medicine’s Agency (AIFA) from 2015 to 2018 and at present sits on the Institutional Review Boards for Clinical Research.

Academic lecturers: 0

Guest lecturers: 6

Laboratory: 0

Title	General principles of drug and cosmetic regulation (3 ECTS)
Program	COSMETIC REGULATION · General principles that govern cosmetic regulation and substantial differences compared to pharmaceutical and medical device 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 REACH 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
Textbooks	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).
Objectives	The aim of the course is to give an overview of the requirements for cosmetic and medicinal products to enter national or global markets and to highlight the strong differences between the two.
Prerequisites	None.
Teaching methods	Seminars.
Expected Results	Students should: · Navigate through guidelines, regulations and laws to design adequate strategies for products; · Know where to find the relevant guidelines to follow in a pre-clinical setting; · Be aware of the presence of guidelines for particular activities.
Exam modality	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 (minimum score will be 18/30 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. Utilising a specific format, students will briefly describe the regulatory framework in their own country related to cosmetic 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 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 and describe the peculiarities of that product compared to the entire cosmetic regulation, but the paper should not cover the general European cosmetic regulation. Evaluation will be done on quality of the information, on references, and ability to answer at scheme provided. Turnitin report is mandatory.

TITLE

General principles of drug and cosmetic regulation (3 ECTS)

PROGRAM

COSMETIC REGULATION

· General principles that govern cosmetic regulation and substantial differences compared to pharmaceutical and medical device 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

REACH

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

TEXTBOOKS

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).

OBJECTIVES

The aim of the course is to give an overview of the requirements for cosmetic and medicinal products to enter national or global markets and to highlight the strong differences between the two.

PREREQUISITES

None

TEACHING METHODS

Seminars.

EXPECTED RESULTS

Students should:
· Navigate through guidelines, regulations and laws to design adequate strategies for products;
· Know where to find the relevant guidelines to follow in a pre-clinical setting;
· Be aware of the presence of guidelines for particular activities.

EXAM MODALITY

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 (minimum score will be 18/30 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. Utilising a specific format, students will briefly describe the regulatory framework in their own country related to cosmetic 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 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 and describe the peculiarities of that product compared to the entire cosmetic regulation, but the paper should not cover the general European cosmetic regulation. Evaluation will be done on quality of the information, on references, and ability to answer at scheme provided. Turnitin report is mandatory.

Last modified: September 15, 2023

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