Ateneo - UPO

The course aims to provide information on the requirements that medicines must possess to obtain marketing authorization and access the market. It is also proposed to describe the strategies and methodologies applied in the economic evaluation, in the price negotiation and reimbursement of drugs.

For module of Technology Aspects and Regulation of Medicinal Products
The body of European Union legislation in the pharmaceutical sector EUDRALEX

For module of Economy and Regulation of Drug
Part 1: Pisano G, Science Business, 2006, Harvard Business School Press;
Gianfrate F, Il mercato dei farmaci tra salute e business, Franco Angeli Editore, 2014.

Part 2: Readings list provided by the professor.

Part 3: Mennini FS, Cicchetti A, Fattore G, Russo P. La Valutazione Economica dei Programmi Sanitari. Il Pensiero Scientifico ed. 2011. Terza Edizione.

The aim of the first part of the course is to provide students with information and knowledge on the processes that, starting with the identification of a New Chemical Entity (NCE), lead to the marketing of medicinal products, focusing both on the scientific aspects (drug discovery, formulation development, manufacture and production controls) and procedural and regulatory ones (patents, MA).
The second part of the course aims at (i) making students aware of the regulatory context of the pharmaceutical companies, of innovation processes in the pharmaceutical industry, on the organizational structure and the main functions of the pharmaceutical companies (ii) and carrying out drugs comparative analysis from an economic perspective.
Knowledge and competences will be applied to case studies focused on negotiation of prices and reimbursement and exercises on economic evaluation and budget impact analysis.
Students are expected to be more autonomous in managing drugs market access issues and to improve communication skills thanks to case-studies discussion and group project.

There are no prerequisites, but it is strongly recommended to attend the training only after having attended and/or passed the examinations of the courses of the first three years and in particular those of Medicinal Chemistry, Pharmacology and Pharmaceutical Technology.

The course is organized in traditional lectures, exercises (on experimental design analysis, economic evaluation and budget impact analysis), case-studies, organisation of groups projects. Students are required to participate fully in class and pull their weight in group work.

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-learning-disabilities

Students 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 examination of Technology Aspects and Regulation of Medicinal Products module will be carried out in oral form. To achieve the final vote, the student must demonstrate that he has understood, and he is able to use the fundamental concepts of each topic.

For Drug Economy and Regulation, grading is based on:
• one written exam (60% of the final grade); all topics discussed during the course will be covered by the final exam, which will include open question (no multiple choice) and exercises
• groups project results (20% of the grade each).

The evaluation will be based on the following criteria:
1. knowledge and theoretical understanding and application of the studied subjects;
2. independence of judgment and ability to link the studied arguments;
3. communication skills and appropriateness in the use of technical language;
4. learning ability.

Technology Aspects and Regulation of Medicinal Products
Pharmaceutical product lifecycle
Exploratory phase
Research phase: preformulation and formulation
Development phase: pharmaceutical development, pre-clinical and clinical Trials (Phase I, II and III)
Marketing and post-marketing

The rules governing the marketing of medicinal products
Intellectual property: fundamentals, procedures; pharmaceutical patent
Marketing Authorization
Manufacturing Authorization
Clinical Trial Authorization
Procedures, Common Technical Document.

The quality in the pharmaceutical industry
Quality System: introduction, references, objectives, quality monitoring. Quality Control and Quality Assurance.
Quality Risk Management: the risk and the risk management, references, QRM process, techniques, case studies
Quality by Design: statistical tools: Design of Experiments
Validation procedures and protocols for product and processes.

Drug Economy and Regulation
First part: pharmaceutical market and its regulation.
The Italian health care system: main aspects and relationships with the industry
The pharmaceutical market: international and national trends. Aggregate trends and their split per main therapeutic areas, distribution systems, reimbursability status, and patent status.
Pharmaceutical market regulation: Pre-Marketing Regulation, Marketing Authorisation, Price and Reimbursement, Managed Market Entry Contracts, Regional and Local Policies (formularies, procurement, distribution systems, actions on prescribing behaviour); the recognition of the innovativeness of medicines by AIFA through the use of domains.

Second part: pharmaceutical companies and their functions. The principles of public health and pharmaceutical governance.
Pharmaceutical companies: organisational structure and main functions
Research and Development: phases, economics, relationships among companies (co-research, co-development, licensing, patent negotiation)
Market access and Public affairs
Marketing and sales. Health and pharmaceutical governance implemented by Central Government, Regions and Health Authorities.

Third part: economic evaluation of drugs
An introduction to Health Technology Assessment
Economic evaluation of drugs: principles, methods, phases. Models of economic evaluations.
Budget impact analysis: differences from the economic evaluation.
Practical examples of budget impact analysis and economic evaluation of drugs.

At the end of course, the student must demonstrate:
- to be able to apply its knowledge to describe the content of the documentation pertaining the medicinal product and to identify and illustrate the methods used to compose such documentation
- to use the specific language of this very specialized discipline and to address the professional responsibilities of the pharmaceutical technologist
- to understand how the environment may influence the performance of the pharmaceutical industry and knowing how to be up-to-date on environmental changes.
- to manage market access for medicines.
- to carry out cost-effectiveness and budget impact analysis.
- to be able to participate in group work focused on market access and value proposition.