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.
- Competencies related to the design and evaluation of studies that are carried out in the clinical development of medicines.
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.
- Attendance and participation in face-to-face classes and other activities (80% of the final grade).
- Assessment of a memory presented by the student (20% of the final grade).
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.
CONTINGENCY PLAN:
Scenario 1 (adapted normality):
- Teaching: the teaching of the expository and interactive seminary classes will be fundamentally face-to-face. The tutorials may be face-to-face and virtual (through the tools of the virtual campus).
- Assessment: continuous formative assessment with a final face-to-face test.
Scenario 2 (distancing; partial restrictions on physical attendance):
- Teaching: expository and interactive teaching may be 50% face-to-face, and will also be carried out telematically using institutional tools and platforms, with synchronous and asynchronous mechanisms. The tutorials will preferably be virtual.
- Assessment: continuous formative assessment, with a complementary final test, preferably telematic.
Scenario 3 (closure of the facilities; impossibility of teaching with physical attendance):
- Teaching: expository and interactive teaching will be carried out exclusively virtual, through institutional tools and platforms, and through synchronous and asynchronous mechanisms. The tutorials will be carried out exclusively by telematic means.
- Assessment: continuous formative assessment with a complementary final test, exclusively telematic in nature. For the three scenarios, the delivery of papers and reports will be done through the virtual campus.
In the three scenarios, in the cases of fraudulent completion of tasks or tests, the provisions of the USC Regulations on the evaluation of student academic performance and review of grades will apply.
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
María Encarnación Beiro González
- Department
- External department linked to the degrees
- Area
- Área externa M.U en Investigación y Desarrollo de Medicamentos
- Category
- External area professional_máx. 30 h
Jose Maria Perez Rubio
- Department
- External department linked to the degrees
- Area
- Área externa M.U en Investigación y Desarrollo de Medicamentos
- Category
- External area professor
Ramiro Couceiro Otero
- Department
- External department linked to the degrees
- Area
- Área externa M.U en Investigación y Desarrollo de Medicamentos
- Category
- External area professional_máx. 30 h
Pablo Óscar Lopez Delgado
- Department
- External department linked to the degrees
- Area
- Área externa M.U en Investigación y Desarrollo de Medicamentos
- Category
- External area professional_máx. 30 h
Fernando Rico-Villademoros Pita
- Department
- External department linked to the degrees
- Area
- Área externa M.U en Investigación y Desarrollo de Medicamentos
- fernando.ricovillademoros [at] cociente.es
- Category
- External area professor
| Monday | |||
|---|---|---|---|
| 16:30-19:30 | Grupo /CLE_01 | Spanish | 5035 Virtual classroom |
| 19:30-20:30 | Grupo /CLIS_01 | Spanish | 5035 Virtual classroom |
| Tuesday | |||
| 16:30-19:30 | Grupo /CLE_01 | Spanish | 5035 Virtual classroom |
| 19:30-20:30 | Grupo /CLIS_01 | Spanish | 5035 Virtual classroom |
| Wednesday | |||
| 16:30-19:30 | Grupo /CLE_01 | Spanish | 5035 Virtual classroom |
| 19:30-20:30 | Grupo /CLIS_01 | Spanish | 5035 Virtual classroom |