ECTS credits ECTS credits: 3
ECTS Hours Rules/Memories Student's work ECTS: 51 Hours of tutorials: 3 Expository Class: 9 Interactive Classroom: 12 Total: 75
Use languages Spanish, Galician
Type: Ordinary subject Master’s Degree RD 1393/2007 - 822/2021
Departments: Pharmacology, Pharmacy and Pharmaceutical Technology, External department linked to the degrees
Areas: Pharmacology, Área externa M.U en Investigación y Desarrollo de Medicamentos
Center Faculty of Pharmacy
Call: Second Semester
Teaching: With teaching
Enrolment: Enrollable | 1st year (Yes)
1. Describe the principles of evaluating the efficacy, safety and effectiveness of pharmacological treatments.
2. Acquire notions, and as far as possible promote attitudes, on the aspects that support the rational use of medications, such as evaluating their efficacy and safety, by critically reading clinical research studies with medications and analyzing the risks associated with its use.
I.- THE EVALUATION OF EFFECTIVENESS. CLINICAL TRIAL:
1. Experimental methodology for evaluating the effectiveness of medications. Drug development. The clinical trial.
2. Clinical trial (I): Phases. Assessment of the response. Main and secondary variables.
3. Clinical trial (II): Types of design. Clinical trials in parallel, crossover, sequential and factorial groups. Explanatory and pragmatic clinical trials.
4. Clinical trial (III): Study population and sample. Inclusion and exclusion criteria. Internal validity and external validity.
5. Clinical trial (IV): Randomization and masking. Placebo effect.
6. Ethical and legal aspects of the clinical trial.
II. THE EVALUATION AND CONTROL OF THE RISKS OF THE USE OF THE DRUGS:
7. Adverse drug reactions: Factors that condition them. Production mechanisms.
8. Pharmacovigilance. Objectives and strategies. Assessment of causality.
9. Principles of therapeutic drug monitoring.
III.- EVALUATION OF THE EFFECTIVENESS. SELECTION OF MEDICINES:
10. Literature assessment criteria. Systematic reviews. Meta-analysis.
11. Risk benefit assessment: Evaluation of effectiveness. Evidence based medicine.
12. Criteria for drug selection.
- Ensayos Clínicos en España: Actualización en ética, normativa, metodología y nuevas tecnologías. Coordinadora: Concepción Martínez Nieto. SEFH (Sociedad Española de Farmacia Hospitalaria) & Merck. Mayo de 2017. ISBN: 978-84-697-3116-1 (https://www.sefh.es/bibliotecavirtual/ensayos/Ensayos_clinicos.pdf).
- Blass B. Basic Principles of Drug Discovery and Development. Academic Press. ISBN: 978-1118907276 (2015).
- Rick NG. Drugs: From Discovery to Approval, 3 edición. Wiley-Blackwell. ISBN: 978-1118907276 (2015).
- Biswal S, Jose VM. An Overview of Clinical Trial Operation: Fundamentals of clinical trial planning and management in drug development. Biswal S y Jose VM eds. ISBN: 978-1973576938 (2017)
- Tato Herrero, F. Bases metodológicas de la investigación clínica con medicamentos.© Fernando Tato Herrero. Registro de los derechos de Propiedad intelectual: Núm. de Asiento Registral, 03/2016/436 (pendiente de publicación).
- Royal Decree 1090/2015, of December 4, which regulates clinical trials with drugs, the Research Ethics Committees with drugs and the Spanish Registry of Clinical Studies.
- Royal Legislative Decree 1/2015, of July 24, which approves the consolidated text of the Law on guarantees and rational use of medicines and health products.
- Regulation (EU) No 536/2014 Of the European Parliament and of the Council of April 16, 2014 on clinical trials of medicinal products for human use, and which repeals Directive 2001/20 / EC.
- Instructions document from the Spanish Agency for Medicines and Health Products for conducting clinical trials in Spain.
Related content at the following web addresses:
- https://www.aemps.gob.es
- https://www.ema.europa.eu/en
- https://www.fda.gov/drugs
- Best Project. Spanish Technological Platform for Innovative Medicines (https://www.medicamentos-innovadores.org).
- Databases, search engines and thematic indexes related to Health Sciences.
- EZproxy service that allows access to electronic resources subscribed by BUSC and those subscribed through the BUGALICIA Consortium, for all members of the university community.
LEARNING OUTCOMES:
1.1. Know the principles of the evaluation of the efficacy, safety and effectiveness of pharmacological treatments: C. Basic CB2-CB5; C. General CG3-CG5-CG6-CG7-CG9-CG10-CG11; C. Specific CE2-CE3-CE6-CE9-CE10-CE11-CE12-CE13-CE14-CE15.
1.2. Know the stages of a clinical investigation: Basic C. CB1-CB2-CB3-CB4-CB5; C. General CG1-CG3-CG4-CG5-CG6-CG7-CG8-CG9-CG10; C. Specific CE1-CE2-CE3-CE4-CE5-CE6-CE7-CE9-CE10-CE11-CE12-CE13-CE14-CE15
1.3. Know the ethical and legal aspects of a clinical trial: C. Basic CB2-CB3-CB5; C. General CG6-CG9-CG11; C. Specific CE1-CE2-CE-9-CE12-CE13.
1.4. Know the basic aspects of the pharmacovigilance system: C. Basic CB2-CB3-CB5; C. General CG3-CG5-CG6-CG7-CG9-CG10-CG11; C. Specific CE2-CE4-CE6-CE9-CE10-CE11-CE12-CE13-CE14-CE15.
1.5. Acquire awareness about the need for rational use of drugs: Basic C. CB2-CB3-CB5; C. General CG3-CG5-CG6-CG7-CG9-CG10-CG11; C. Specific CE1-CE6-CE9-CE10-CE12-CE13-CE14.
1.6. Do a critical reading of scientific articles about clinical research studies with drugs: C. Basic CB1-CB2-CB3-CB4-CB5; C. General CG1-CG2-CG3-CG4-CG5-CG6-CG7-CG8-CG9-CG10-CG11; C. Specific CE1-CE2-CE3-CE4-CE5-CE6-CE9-CE10-CE11-CE12-CE13-CE14-CE15.
1.7. Know through external collaborators from the industry, different professional opportunities in the field of Clinical Drug Development: C. Basic CB5; C. General CG6-CG8-CG9-CG10-CG11; C. Specific CE1-CE2-CE3-CE4-CE5-CE6-CE7-CE9-CE10-CE11-CE12-CE13-CE14-CE15.
* Basic Competences of Master's studies in Spain according to RD 861/2010 that modifies RD 1393/2007
CB1. Possess and understand knowledge that provides a basis or opportunity to be original in the development and / or application of ideas, often in a research context.
CB2. That students know how to apply the acquired knowledge and their ability to solve problems in new or little-known environments within broader (or multidisciplinary) contexts related to their area of study;
CB3. That students are able to integrate knowledge and face the complexity of formulating judgments based on information that, being incomplete or limited, includes reflections on the social and ethical responsibilities linked to the application of their knowledge and judgments;
CB4. That students know how to communicate their conclusions –and the knowledge and ultimate reasons that support them– to specialized and non-specialized audiences in a clear and unambiguous way;
CB5. That students possess the learning skills that allow them to continue studying in a way that will be largely self-directed or autonomous.
General competences
CG1. Critical and analytical skills in the field of drug research and development
CG2. Creative ability to propose and carry out new approaches in drug R&D.
CG3. Advanced knowledge of information and communication technologies.
CG4. Ability to plan, prepare and execute research or development projects in the field of medicines.
CG5. Ability to write, analyze, interpret and present technical reports.
CG6. Ability to adapt to the evolution of work tools
CG7. Ability to evaluate and confront criteria and address decision-making.
CG8. Ability to transmit information on drug research and development.
CG9. Ability to work in multidisciplinary and multicultural groups.
CG10. Ability to incorporate innovation and technological advances in the field of medicines into their field of work.
CG11. Arrangement of routine techniques for autonomous learning
Specific skills
CE1. Acquisition of solid multidisciplinary research training
CE2. Ability to identify, formulate and solve problems in pharmacology and / or pharmaceutical development.
CE3. Ability to define problems and identify critical points and implement solutions in tasks related to drug R&D.
CE4. Ability to design drug R&D experiments
CE5. Acquisition of skills to work in a research laboratory in pharmacology and / or pharmaceutical development.
CE6. Ability to use work tools and instruments commonly used in drug R&D.
CE7. Ability to design drugs and / or medications in the working conditions of pharmaceutical research laboratories.
CE8. Innovation capacity in the development of new drugs and new drug delivery systems.
CE9. Knowledge of the regulatory and economic-financial aspects of drug R&D projects.
CE10. Ability to apply analytical and computer methods and other tools to the analysis of problems in the field of pharmaceutical research and development
CE11. Ability to elaborate and develop work protocols in the area of R&D of medicines.
CE12. Ability to apply quality criteria
CE13. Ability to communicate with the scientific community and with society in general, on issues related to medicine
CE14. Ability to advise in the field of drug research and development.
CE15. Ability to update knowledge in the field of drug R&D.
It is based on the exposition of topics of a theoretical nature and the holding of seminars, the contents of which are interrelated, seeking to provide a vision of the set of knowledge and skills that a professional must possess for solving problems in a real work environment.
1. Attendance and participation: 80% of the final grade; competencies: CB1, CB2, CB3, CB4, CB5
CG1, CG2, CG3, CG4, CG5, CG6, CG7, CG8, CG9, CG10, CG11
CE1, CE2, CE3, CE4, CE5, CE6, CE7, CE9, CE10, CE1, CE12, CE13, CE14, CE15.
2. Individual memory: 20% of the final grade; competencies: CB1, CB2, CB3, CB4, CB5
CG1, CG2, CG3, CG4, CG5, CG6, CG7, CG8, CG9, CG10, CG11
CE1, CE2, CE3, CE4, CE5, CE6, CE7, CE9, CE10, CE1, CE12, CE13, CE14, CE15
Theory: 12 hours in person + 24 hours of student personal work
Seminars: 8 hours in person + 29 hours of student personal work
Assessment: 2 hours in person
TOTAL: 22 hours in person + 53 h personal work of the student = 75 total hours
- The active participation of the student in the proposed activities is recommended.
- Likewise, it is important the handling of the recommended bibliography for the subject by the student.
- You must have a basic knowledge of English and computers.
Ma Del Pilar Fernandez Rodriguez
- Department
- Pharmacology, Pharmacy and Pharmaceutical Technology
- Area
- Pharmacology
- Phone
- 881812401
- mdelpilar.fernandez [at] usc.es
- Category
- Professor: University Lecturer
Manuel Freire-Garabal Nuñez
Coordinador/a- Department
- Pharmacology, Pharmacy and Pharmaceutical Technology
- Area
- Pharmacology
- Phone
- 881812248
- manuel.freire-garabal [at] usc.es
- Category
- Professor: University Professor
| Monday | |||
|---|---|---|---|
| 16:30-19:30 | Grupo 1/CLE_01 | Spanish | PENDIENTE DE ASIGNACIÓN |
| 19:30-20:30 | Grupo 1/CLIS_01 | Spanish | PENDIENTE DE ASIGNACIÓN |
| Tuesday | |||
| 16:30-19:30 | Grupo 1/CLE_01 | Spanish | PENDIENTE DE ASIGNACIÓN |
| 19:30-20:30 | Grupo 1/CLIS_01 | Spanish | PENDIENTE DE ASIGNACIÓN |
| Wednesday | |||
| 16:30-19:30 | Grupo 1/CLE_01 | Spanish | PENDIENTE DE ASIGNACIÓN |
| 19:30-20:30 | Grupo 1/CLIS_01 | Spanish | PENDIENTE DE ASIGNACIÓN |
| Thursday | |||
| 16:30-19:30 | Grupo 1/CLIS_01 | Spanish | PENDIENTE DE ASIGNACIÓN |