CODE 105108 ACADEMIC YEAR 2023/2024 CREDITS 2 cfu anno 3 BIOTECNOLOGIE 8756 (L-2) - GENOVA SCIENTIFIC DISCIPLINARY SECTOR MED/46 LANGUAGE Italian (English on demand) TEACHING LOCATION GENOVA SEMESTER 2° Semester TEACHING MATERIALS AULAWEB OVERVIEW The course offers the student a broad view on the activities of Good Manufacturing Practices (GMP) which together represent a concept of concepts that identify important aspects in the production of a drug. The application of the GMP Guidelines is mandatory by law in pharmaceutical manufacturing. A pharmaceutical workshop must comply with the GMP standards, compliance which must be confirmed through inspection visits by the Competent Authority, which for Italy is the Italian Medicines Agency (AIFA). The course discusses the legislative aspects that regulate the processing and organization of drug production facilities. AIMS AND CONTENT LEARNING OUTCOMES Know the legislation and indicate the operational tools; Understand current EU and FDA requirements for drug production and control; Design, implement and maintain a compliant system; Identify the roles and responsibilities of key figures as required by regulations; Management and evaluation of its Quality System. AIMS AND LEARNING OUTCOMES The training includes a broad knowledge of the legislation and of the operational tools for the production and control of drugs; design, implement and maintain a compliant system for pharmaceutical processing; Identify the roles and responsibilities of key figures in production processes as required by regulations; management and evaluation of its Quality System. The learning outcomes will be verified on an ongoing basis with extensive interactive discussions on the topics covered and through a final evaluation exam. PREREQUISITES Basic biology knowledge TEACHING METHODS the final assessment of learning concerns an interview to verify the acquired knowledges SYLLABUS/CONTENT Notes on Biological and Biotechnological Medicines Advanced therapies: medicinal products Legislation governing the production of medicinal products in advanced therapies Definition and characteristics of Good Standard Practices: GLP, GMP, GCP Regulatory agencies: AIFA, EMA, FDA Regulatory inspections Assay centers and clinical study processing Operation of GLP: Management of laboratories; Study Director; Quality Control Unit, Guidelines Behavioral rules in Cell Factory Cell Factory facilities Processing methods in the Cell Factory: classification of areas Staff training In GMP Sanitization of GMP premises TEACHERS AND EXAM BOARD MADDALENA MASTROGIACOMO Exam Board MADDALENA MASTROGIACOMO (President) GILBERTO FILACI CHIARA GENTILI LESSONS Class schedule The timetable for this course is available here: Portale EasyAcademy EXAMS Exam schedule Data appello Orario Luogo Degree type Note 18/06/2024 14:00 GENOVA Orale 03/07/2024 14:00 GENOVA Orale 05/09/2024 14:00 GENOVA Orale