ECTS credits ECTS credits: 6
ECTS Hours Rules/Memories Student's work ECTS: 102 Hours of tutorials: 6 Expository Class: 18 Interactive Classroom: 24 Total: 150
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: Pharmacy and Pharmaceutical Technology, Pharmacology, Área externa M.U en Investigación y Desarrollo de Medicamentos
Center Faculty of Pharmacy
Call: First Semester
Teaching: With teaching
Enrolment: Enrollable | 1st year (Yes)
- To provide an overview of the overall process of drug discovery and of development of new medicines.
- To give an account of the high throughput procedures used in the screening of new chemical entities (NCE) as drug candidates.
- To describe the pharmacological, toxicological and biopharmaceutical criteria that should be taken into account for the screening of new drugs.
- To present the structure of the preformulation programs and the pharmaceutical development activities.
- To present the structure of the preclinical and clinical studies.
- To give an account of the current concepts of quality assurance in the pharmaceutical industry.
- To describe the procedure and the structure of the dossier needed for registering new medicines.
- To give an account of the objective and the planning of post-marketing clinical studies.
Thematic block I- Discovery of new drugs and development of new medicines. Approach and steps.
Thematic block II- High throughput procedures for screening of new chemical entities (NCE) as drug candidates. Pharmacological, toxicological and biopharmaceutical criteria to take into account for the screening of new drugs.
Thematic block III- Preformulation studies and pharmaceutical development. Approach and objectives. Industrial production of medicines.
Thematic block IV- Preclinical trials. Clinical trials before registration of a new medicine and postmarketing.
Thematic block V- Registration of new medicines. Registration dossiers: quality, safety, efficacy.
- Raviña Rubira, E. Medicamentos. Un viaje a lo largo de la evolución histórica del descubrimiento de fármacos (I y II). Servizo de Publicacións e Intercambio Científico da Universidade de Santiago de Compostela, 2008.
- Preformulation in solid dosage form development. Moji Christianah Adeyeye, Harry G. Brittain (editores). New York : Informa Healthcare, cop. 2008.
- AGEMED web page. http://www.agemed.es/
- Normas de correcta fabricación : medicamentos de uso humano y uso veterinario. Madrid: Ministerio de Sanidad y Consumo, 2008.
- EMEA web page. http://www.emea.europa.eu/htms/human/raguidelines/application.htm
- Ensayos clínicos : diseño, análisis e interpretación. Alvarez Cáceres, Rafael. Madrid: Díaz de Santos, D.L. 2005.
- To understand the overall process of drug discovery.
- To understand the transformation process of a drug in a medicine.
- To acquire skills in the use of selection criteria for new drugs.
- To acquire ability to apply the basic concepts of quality assurance in the pharmaceutical industry.
- To acquire ability to interpret the different sections of a registration dossier.
Scene 1: Lectures, interactive seminars and practical sessions of compulsory attendance.
Scene 2: The expository and interactive classes will be face-to-face for a number of students who, depending on the capacity of the classroom, can comply with the security regulations established. For the rest of the students, they will be synchronous. Students will take turns between these two types of teaching. It may be that, due to unsuccessful causes, some of the classes take place asynchronously, which will be communicated to the students in advance. The tutorials will be carried out electronically and will require an appointment.
Scene 3: The exhibition, interactive classes and tutorials will be non-face-to-face, through institutional computer and audiovisual means: Office 365 and Moodle (Virtual Campus).
Scene 1: Attendance at lectures and work done in practical classes and seminars (50%), and final exam consisting in solving case studies related to the subject (50%).
Scene 2: The evaluation will consist of the completion of a non-face-to-face final test that will account for 50% of the final grade and the remaining 50% corresponds to a continuous evaluation carried out during the interactive classes and practical classes.
Scene 3: The evaluation will consist of the completion of a non-face-to-face final test that will account for 70% of the final grade and the remaining 30% corresponds to a continuous evaluation carried out during the interactive classes and the different activities that replace the in-person activities.
Scenarios 2 and 3: Evaluation activities that cannot be carried out in person will be carried out telematically through institutional tools: Office 365 and Moodle (Virtual Campus). In this case, a series of measures will have to be adopted that will require the students to have a device with a microphone and camera as long as no suitable evaluation software is available. Students may be required for an interview to comment on or explain part or all of the test.
In the event of fraudulent exercises or tests, the provisions of the Regulations for the Evaluation of Students' Academic Performance and Grade Review will apply.
Total ECTS credits: 6, distributed as follows:
- Theory (Assistance to lectures on thematic blocks): Class hours: 30; hours of student personal work: 45. 3 ECTS credits.
- Practice (access to databases, consultation and discussion of AGEMED and EMA documents) Class hours: 16; hours of student personal work: 24. 1.6 ECTS credits.
- Other activities: Preparation of material for seminars: hours of student personal work: 15. Presentations: hours of class: 10. 1 ECTS credits.
- Evaluation (Preparation and resolution of the exam). Class hours: 4; hours of student personal work: 6. 0.4 ECTS credits.
Basic knowledge of English and managing software.
En el escenario 2 los exámenes se realizarán de forma presencial/telemática en función de la situación sanitaria.
Para los casos de realización fraudulenta de ejercicios o pruebas, se aplicará lo establecido en el Reglamento para la evaluación del desempeño académico de los estudiantes y la revisión de calificaciones.
Angel Joaquin Concheiro Nine
Coordinador/a- Department
- Pharmacology, Pharmacy and Pharmaceutical Technology
- Area
- Pharmacy and Pharmaceutical Technology
- Phone
- 881814886
- angel.concheiro [at] usc.es
- Category
- Professor: University Professor
Carmen Isabel Alvarez Lorenzo
- Department
- Pharmacology, Pharmacy and Pharmaceutical Technology
- Area
- Pharmacy and Pharmaceutical Technology
- Phone
- 881814877
- carmen.alvarez.lorenzo [at] usc.es
- Category
- Professor: University Professor
Manuel Campos Toimil
- Department
- Pharmacology, Pharmacy and Pharmaceutical Technology
- Area
- Pharmacology
- Phone
- 881815006
- manuel.campos [at] usc.es
- Category
- Professor: University Lecturer
Matilde Yañez Jato
- Department
- Pharmacology, Pharmacy and Pharmaceutical Technology
- Area
- Pharmacology
- Category
- Professor: Temporary supply professor to reduce teaching hours
| Monday | |||
|---|---|---|---|
| 16:30-18:30 | Grupo /CLE_01 | Spanish | 5035 Soil Science Seminar Room |
| 18:30-20:30 | Grupo /CLIS_01 | Spanish | 5035 Soil Science Seminar Room |
| Tuesday | |||
| 16:30-18:30 | Grupo /CLE_01 | Spanish | 5035 Soil Science Seminar Room |
| 18:30-20:30 | Grupo /CLIS_01 | Spanish | 5035 Soil Science Seminar Room |
| Wednesday | |||
| 16:30-18:30 | Grupo /CLE_01 | Spanish | 5035 Soil Science Seminar Room |
| 18:30-20:30 | Grupo /CLIS_01 | Spanish | 5035 Soil Science Seminar Room |
| Thursday | |||
| 16:30-18:30 | Grupo /CLE_01 | Spanish | 5035 Soil Science Seminar Room |
| 18:30-20:30 | Grupo /CLIS_01 | Spanish | 5035 Soil Science Seminar Room |
| Friday | |||
| 16:30-18:30 | Grupo /CLE_01 | Spanish | 5035 Soil Science Seminar Room |
| 18:30-20:30 | Grupo /CLIS_01 | Spanish | 5035 Soil Science Seminar Room |