Over the last decade, radical changes in products developed and marketed by the biopharmaceutical industry, as well as a growing interest in improving the efficiency and effectiveness of production, have encouraged an evolution in the technologies and processes in use to produce the latest generation of biopharmaceutical products.
The Master in Development, Manufacturing and Authorization of Biopharmaceuticals aims to train experts able to manage the different processes of industrial development of laboratories with biotechnological and pharmacological characterization, to respond to the growing demand for highly qualified operators from companies and institutions in the sector.
The master aims to prepare specialized personnel with a high level of qualification, able to cover various professional positions within the biopharmaceutical drugs world.

These professionals will be qualified as:
• Manager/Director of laboratories with biotechnological and pharmacological characterization.
• Coordinator of development and monitoring programs of applied biotechnologies in human health, regarding the industrial development of biopharmaceutical products, the industrial aspects of biotechnological drugs production, and the management of scientific and process-related data with artificial Intelligence (AI).
• Expert in management of the regulatory aspects of the market authorizations, of the ethical and legal implications of the marketing of biopharmaceuticals with aspects of environmental protection and sustainability.

Contact with the many companies in the Master's program, regulatory bodies such as AIFA and the Istituto Superiore di Sanità as well as the internship and the experience of dialogue and confrontation with national and international Pharmaceutical Industry managers opens up a wide range of possibilities for participants.

Participants will be guided through a personalised career orientation path

The Master is structured in 1500 hours, for a total of 60 training credits (CFU), of which:

• 240 hours of face-to-face lectures;
• 375 hours of internship;
• 125 hours for the final test.

The remaining hours will be dedicated to individual study, workshops, discussion – individually and in groups – of leading cases, testimonials, and company visits, aimed at ensuring the full acquisition of conceptual tools and applications.

The second edition of Master Training Program will start in September 2023. Classes will be held online, in live streaming, and will generally occur on Fridays (9.00 a.m. – 1.00 p.m. and 2.00 p.m. – 6.00 p.m.) and Saturdays (9.00 a.m. -1.00 p.m.). Once every 4-6 weeks students will be invited to join a class that will take place in Modena in-person and simultaneously online.

TEACHING MODULES & STAFF

The Master develops the following topics:

1) Industrial development and manufacturing;
2) Clinical studies of biopharmaceutical products and new concepts in trial design and statistical approaches;
3) Data management in the various industrial processes and exploitation;
4) Regulatory aspects for the market authorizations;
5) Market access and sustainability.

The teaching staff is composed of professors, researchers from private and public institutions, corporate directors, personnel managers, and qualified experts.

375 HOURS OF INTERNSHIP: WHEN AND WHERE

Internships will begin once lectures are over and will take place during weekdays, following the company’s working hours.

The internship period can be carried out at some selected companies among the list of our partners. Internship positions are available in Italy as well as in the other Countries of the collaborating partners.

The master's degree, which is international in nature and involves Italian and foreign faculty members from biopharmaceutical industries as well as experienced faculty members from Unimore, aims to prepare specialized personnel with a high level of qualification, capable of filling various professional positions within the biopharmaceutical drug world.