Clinical pharmacology
Objectives
To provide opportunities for students to: Develop an understanding of clinical research importance in the evaluation and authorization of a new medication. Acquire basic information about the regulation process to conduct a clinical trial Identify the ethical principles to conduct a clinical trial Develop the knowledge to organize/create a clinical research unit Identify and plan the resources and facilities required to conduct a clinical trial in a research unit Enhance Good Clinical Practices in a clinical trial context Acquire information about an Investigator responsibilities Develop the quality requirements in a clinical research unit Develop the practical knowledge in how an investigator site works |
General characterization
Code
11217
Credits
3
Responsible teacher
Dra. Elsa Branco
Hours
Weekly - Available soon
Total - Available soon
Teaching language
Portuguese
Prerequisites
Bibliography
Site CEIC: www.ceic.pt Site INFARMED: www.infarmed.pt Site CNPD: www.cnpd.pt Site EMA: www.ema.europa.eu Site FDA: www.clinicaltrials.gov Site ICH: Lei 21/2014 de 16 de abril Lei 7372015 de 27 de julho Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects ICH Topic E 6 (R1) Guideline for Good Clinical Practice |
Teaching method
The lectures will be on central building and pratical classes will be on a clinical research site (option A) or in Pharmaceutical industry (option B). |
Evaluation method
The classification will include a final multiple options exam that could be used for a GCP (Good Clinical Practice) certification.
Subject matter
Module 1 - Development plan for a medical product Module 2 - Clinical trials basic concepts Module 3 - Ethical and legal aspects of clinical research Module 4 - Good Clinical Practice guidelines Module 5 - Clinical trial site management Module 6 - Quality management in clinical research area Module 7 - Medical Affairs e Health Outcome Research Module 8 A- Visit a clinical research site Module 8 B- Medical Affairs activity |