Ateneo - UPO

The teaching want to give an understanding about the different stages that characterize the life cycle of a product that contain a new therapeutic agent, from the inception to the medicine withdrawal from the market.
Besides it has the purpose to describe the rules governing medicinal products in Italy and in the EU and, in particular, the requirements from the regulatory athorities for getting the marketing authorization of the product. The strategies and methodologies implemented by the pharmaceutical companies to satisfy these requirements are detailed.

The body of European Union legislation in the pharmaceutical sector

The aim 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).

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 will be delivered mainly in form of lectures (in classroom or as audio lessons). Some seminars are planned, carried out by experienced people from pharmaceutical industry, which will illustrate the practical application of the exposed theoretical concepts. Occasionally, students will be invited to respond jointly to questions on topics already treated and to recover supplementary educational material on AIFA web sites, EMA and FDA

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 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. 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.

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.

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. Moreover, he will be able to assess the implications and results of studies aimed at obtaining the marketing authorization for a medicinal product