Checking date: 10/07/2020

Course: 2020/2021

Quality processes in the biomedical industry. Regulatory basis
Study: Master in Biomedical Technologies Management and Development (287)

Coordinating teacher: JORCANO NOVAL, JOSE LUIS

Department assigned to the subject: Department of Bioengineering and Aerospace Engineering

Type: Compulsory
ECTS Credits: 5.0 ECTS


Students are expected to have completed
Bachelor courses closely related to Biochemistry and/or Cellular and Molecular Biology.
Competences and skills that will be acquired and learning results.
BASIC COMPETENCES CB6. Acquire knowledge and understanding to provide the basis to develop and/or apply original ideas, often in a research context. CB7. Apply the acquired knowledge and the ability to solve problems in new contexts within broader (or multidisciplinary) contexts related to their field of study. CB8. To be able to integrate the acquired knowledge and handle complexity of formulate judgments based on incomplete or limited information, including reflections on social and ethical responsibilities linked to the application of their knowledge and judgments. CB9. To be able to communicate their conclusions and thoughts to a specialized and non-specialized audience in a clear and unambiguous manner. CB10. Learn skills that will enable the students to continue their studies. GENERAL COMPETENCES CG1. Achieve a multidisciplinary scientific view, with a clear translational orientation and applied in the field of biomedical science and technology. CG3. Ability to lead and manage groups and research teams, and also to promote teamwork, knowledge management and competitive intelligence. CG4. Ability to analyze, synthesize and apply knowledge to propose original solutions to biomedical problems. CG5. Develop abilities to identify and understand the social needs and to provide scientific and technological solutions in the biomedical field. CG6. Identify the keys of technology transfer in the Spanish and in the EU market and understand the basis for the management and building of a biomedical based company. SPECIFIC COMPETENCES CE7. Learn the methodology and fundamentals of evidence-based clinical research. CE8. Analyse the drug development process, from the discovery phase to the clinical research phases prior to registration. CE9. Learn the requirements of the regulatory agencies for the different phases of biomedical research, from preclinical to clinical. LEARNING RESULTS Learn the requirements and the importance of regulatory issues in the research and development process of Advanced Therapy Medicinal Products.
Description of contents: programme
a. Introduction to pharmaceutical quality systems - GMP standards. Origin and development - Quality Systems and Personal. Facilities and Equipment. - Production and Quality Control - Manufacturing and analysis by contract, claims, withdrawals, audits and administrative procedure in inspections b. Regulatory agencies of different countries (AEMPS, MHRA, Paul Ehrlich Institute) and EMA and FDA central agencies. Regulatory aspects in Asia c. Manufacturing: - GMP, GLPs, authorizations and requirements. - Legislation of sanitary products. - ISO13485 and standards required for the manufacture of ATMPs required d. Drug Registry and marketing authorization e. Clinical trial authorization f. PEI (IMPD), CTD etc. g. CE Marking h. Examples of Spanish companies
Learning activities and methodology
LEARNING ACTIVITIES - Theoretical classes - Practical classes - Theoretical-practical classes - Tutorships TEACHING METHODOLOGIES - Teacher explanations supported with audiovisual media and information technology, in which the main concepts of the subject are developed and the reference literature is provided to supplement student learning. - Critical reading of international references recommended by the professor: journal papers, reports and manuals for further discussion in class, to enhance and consolidate the knowledge acquired. - Solving practical cases, presented by the professor to the students either individually or in groups. Debates - Presentation and discussion in class, under the moderation of the professor, of subjects related to the course.
Assessment System
  • % end-of-term-examination 60
  • % of continuous assessment (assigments, laboratory, practicals...) 40

The course syllabus and the academic weekly planning may change due academic events or other reasons.