Module Details

Regulation and evidence for market access and Pharmaceutical market management

FA0452

Course
Regulation and evidence for market access and Pharmaceutical market management
Code
FA0452
Academic Year
2026/2027
Curriculum Year
2023/2024
Degree Programme
PHARMACEUTICAL CHEMISTRY AND TECHNOLOGY
Curriculum
000 - Generico
Course coordinator
Credits
13
Lecture Hours
104
Scientific Disciplinary Sector (SSD)
SECS-P/07 - Business Administration
Course Type
Single-subject learning activity
Course Delivery
OPZ - Opzionale
Year
4
Teaching period
Annuale
Campus
NOVARA
Teaching language
Italian
Course Contents
The course aims to provide students with the tools and content to analyze and support the market access process for a drug.
The course will address:
a) pharmaceutical spending analysis and containment measures;
b) the use of cost-effectiveness criteria to guide institutional decisions;
c) stakeholders identification and positioning: e.g. Agenzia Italiana per il Farmaco (AIFA) and Regions;
d) the national and international regulatory framework, the drug approval process, price negotiation and regional access;
e) the structure of the National Health System (NHS), including comparisons with other health systems, the importance of measuring health outcomes;
f) the appropriateness of sources, their identification, the use of databases, and data processing to generate evidence.
Reference Texts
Articles and other sources suggested during the lectures
Learning Outcomes
By the end of the course, students will develop the following skills:
1. Knowledge of the pharmaceutical market and its peculiarities compared to other production sectors;
2. Knowledge of the main economic evaluation methods (Health Technologies Assessment)
3. Knowledge of the structure of our National Health System and other existing healthcare systems
4. The ability to identify available data sources and process data
5. The ability to produce cost-effectiveness evidence and scientifically examine cost-effectiveness studies
Prerequisites
Students should have been approved in the course of Economics and Mangement of the second year
Teaching Methods
Lectures; Exercises and work in group; open discussions; Student presentations of case studies; Stakeholder testimonials
Additional Information
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/servicesstudents-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.
Assessment Methods
1) Students will be partially evaluated during class exercises
2) Written test with closed questions, exercises and open questions
Detailed Syllabus
This course is designed to provide CTF students with a comprehensive overview of the pharmaceutical market, the National Health Service (NHS), and regulatory stakeholders. A focus is placed on the study of Health Technology Assessment methods and their applications. The tools provided to students include identifying databases with relevant information in terms of costs and effectiveness, measuring health outcomes, and developing graphs and trends. This knowledge represents a fundamental asset for working in the pharmaceutical industry, particularly in market access placements. The course is structured into four main modules that focus on the following topics: 1) The pharmaceutical market: regulation and structure 2) The principles of health technology assessment and their application to provide evidence 3) The structure of healthcare systems in Western countries, with particular reference to the Italian National Health System (SSN) 4) Data source identification and data processing. 
Expected Learning Outcomes
By the end of the course, students will develop the following skills:
1. Knowledge of the pharmaceutical market and its peculiarities compared to other production sectors;
2. Knowledge of the main economic evaluation methods (Health Technologies Assessment)
3. Knowledge of the structure of our National Health System and other existing healthcare systems
4. The ability to identify available data sources and process data
5. The ability to produce cost-effectiveness evidence and scientifically examine cost-effectiveness studies
Last update:09-09-2026 00:14:31