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: www.ich.org

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

 

Programs

Programs where the course is taught: