Ateneo - UPO

Module 1 (1 CFU): intellectual property.
This module will deal with intellectual property protection, giving the student sufficient information to be able to undergo a prior art search, write a patent and evaluate the solidness of patents. The topics covered will be: the importance of intellectual property and trademarks, the scope of patents, brief history and definitions, prior art searches, novelty and inventiveness, the person skilled in the art, databases used, filing, examination, publication, approval, maintenance, claims, unitary patent, SPC waiver, classification of patents in the pharmaceutical sciences, litigations. Several examples will be shown.

Module 2 (1 CFU): regulatory affairs.
This module will deal with describing the role of the regulatory affairs professional, the main regulatory districts worldwide, and the general framework of drug and advanced therapy medicinal products (ATMPs) approval, including the ICH. The course will then focus on drug and ATMP approval in Europe and Italy describing, with examples, role and organization of both EMA and AIFA in the drug development, approval, and maintenance of medicinal products. Specific regulations, i.e., for orphan drugs, compassionate uses, etc., will be also covered.

Module 3 (2 CFU): pharmacoeconomics and market access.
This module will show the main methodologies that determine the drug value, how drug prices are set, also describing on a comparative basis the different Health Technology Assessment (HTA), market access and Price and Reimbursement (P&R) processes in European and non-European countries.

Ad hoc readings

At the end of the course, the student will learn the role of regulatory affairs professionals, and of national and European regulatory agencies, the principal registration pathways, and market access (marketing authorization MA). Moreover, the student will learn the techniques of economic evaluation applied to drugs, Health Technology Assessment (HTA), market access and price & reimbursement (P&R) from a national and international perspective.

None

The course includes lectures in the classroom with slide projection, practical applications, and exercises.

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The achievement of the learning objectives will be assessed through a final multiple-choice test (32 questions) including also simple exercises. The test will assess the knowledge of the principal registration and early access pathways, knowledge of EU, national and local legislation for correct access and maintenance of MAs. Moreover, the test will assess the knowledge of the main pharmacoeconomic analysis techniques and the knowledge of HTA, market trends, market accesss, and P&R processes from a national and international perspective.

Module 1 (1CFU): intellectual property.
Intellectual property rights: general information about utility model, industrial design, trademark, copyright. Patent and patentability. Claims and description. Patent convention and protection strategy.
Prior art search and freedom to operate.

Module 2 (1 CFU): regulatory affairs.
Introduction to the role of the regulatory affairs professional. Medicines regulation and main international guidelines. Types of drug registration (national and European). The role of regulatory agencies, their organization, and involvement in the development, registration, market launch and maintenance of the MA.

Module 3 (2 CFU): pharmacoeconomics and market access.
Introduction to pharmacoeconomic analyses. Health Technology Assessment (HTA), market access, Price & Reimbursement (P&R) in the main European countries. Managed Entry Agreements (MEAs). Regional and local policies. Focus on orphan drugs, advanced (ATMPs) and personalized therapies, neglected tropical diseases and drug access in developing countries.

At the end of the course, the student will know the main regulations and laws applied to drugs for human use including advanced therapies, from registration to early access and maintenance of the MA. Also, the student will know the main techniques of pharmacoeconomic analyses and the main HTA, MA and P&R processes from a national and international perspective.