Ateneo - UPO

Specific topics covered include: Good Manufacturing Practice (GMP) procedures and the applicable regulatory framework; differences and similarities between GMP facilities, cell factories, clean rooms, and the laws governing their activities; therapeutic procedures requiring a GMP facility; the Technical Director of a GMP facility and his or her characteristics; innovative processes leading to drug development (GCP); the design and phases of clinical trials for new drugs; certification/accreditation of diagnostic laboratories and procedures for developing a diagnostic kit; internal and external quality controls; general criteria and applicable legislation for patent procedures; biobanking and the preservation of biological samples; and informed consent.

slides and specific articles discussed in class and provided to students

Learn the basics of regulation and the activities of a state-of-the-art laboratory with regards to diagnostics, research and the production of cellular products for clinical use (GMP-grade products)

Background in molecular and cellular biology

Lectures with slides of scientific articles

Female students and students with disabilities or specific disorders of Learning (DSA) or with Special Educational Needs (SEN) may require services and tools specific dedicated to them by contacting the Careers and Services Development and Coordination Staff at Students and by consulting the dedicated page on the website University: https://uniupo.it/it/servizi/servizi-studenti-disabili-e-dsa Female students and students with disabilities, DSA, BES, once taken contact with the University Staff, they can contact the teacher in charge of the course in question to the declension of examination methods, regarding the teaching aspects.

Multiple-choice exam

Good manufacturing practice (GMP) procedures and the regulatory framework; differences and similarities between GMP facilities, cell factories, clean rooms, etc., and the laws governing their activities; therapeutic procedures requiring a GMP facility; the Technical Director of a GMP facility and his or her characteristics; innovative processes leading to drug development (GCP); the design and phases of clinical trials for new drugs; certification/accreditation of diagnostic laboratories and procedures for developing a diagnostic kit; internal and external quality controls; general criteria and regulatory framework for patent procedures; biobanking and the preservation of biological samples; informed consent.

Students will learn the basics of applying Good Manufacturing Practice (GMP) procedures and the relevant regulatory framework; differences and similarities between GMP facilities, cell factories, clean rooms, etc., and the legislation governing their activities; therapeutic procedures requiring a GMP facility; the Technical Director of a GMP facility and his or her characteristics; innovative processes leading to drug development (GCP); the design and phases of clinical trials for new drugs; certification/accreditation of diagnostic laboratories and procedures for developing a diagnostic kit; internal and external quality controls; general criteria and relevant legislation for patent procedures; biobanking and the preservation of biological samples; and informed consent.