Checking date: 04/05/2019


Course: 2019/2020

Innovation in the pharmaceutical Industry: advanced medicines and biotechnology
(12406)
Study: Master in Biomedical Technologies Management and Development (287)
EPI


Coordinating teacher: VELASCO BAYON, DIEGO

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

Type: Compulsory
ECTS Credits: 5.0 ECTS

Course:
Semester:




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 the basis 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 process of evidence-based clinical research and the differential characteristics of Advanced Therapies.
Description of contents: programme
a. Innovation in the pharmaceutical Industry: drug development analysis, from the discovery phase to the clinical research phases prior registration - Drug discovery - Preclinical research required by the regulatory agents: Absorption, Distribution, Metabolism and Excretion (ADME). Toxicology (acute and subacute) - Evidence-based clinical research: Phase I, II, III and IV b. Innovation in biotechnology c. Cell therapy - Production of advanced therapy medicinal products (ATMPs) - Preclinical research - Clinical research d. Gene therapy - Production of advanced therapy medicinal products (ATMPs) - Preclinical research - Clinical reserach
Learning activities and methodology
LEARNING ACTIVITIES - Theoretical classes - Practical classes - Theoretical-practical classes - Tutorships - Group work - Student´s individual work 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. - Reports and projects (working individually or in groups).
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.