Course Objectives
Clinical studies are one of the main strategic areas of Health Development in Portugal. Placing Portugal among the most attractive countries for conducting clinical studies in the European Union, increasing the value created for patients, for the health system, for academia and for society, is the vision assumed by the Portuguese government for the area of Clinical Research (resolution of the Council of Ministers No. 27/2018).
Currently, basic training in the health area does not include this type of skills, and these complementary training are their form of acquisition.
Access Conditions
Graduates in pharmacy or pharmaceutical sciences, other graduates in the field of Health can apply for registration and enrolment.
Learning Language
Portuguese
Learning Objectives
General objectives
The course aims to provide health professionals with knowledge and skills in the field of ethical, regulatory and methodological aspects relevant to the design, implementation and conduct of clinical trials in Portugal. Specific objectives at the end of the course, the trainee will be able to:
1. Recognize the fundamental concepts of clinical trials, including the historical, ethical, and regulatory contexts.
2. Identify the various types and phases of clinical trials relevant to drug development.
3. Interpret the regulatory and legal framework applicable to clinical trials in Portugal and Europe.
4. Recognize the principles of Good Clinical Practice.
5. Describe the components associated with the design of a clinical trial, such as objective, study design and population, intervention and evaluation of efficacy and safety.
6. Describe the process of submission and approval of clinical trials in Portugal.
Relevance: program designed to impart fundamental knowledge about clinical trials, including, ethical and regulatory requirements. The program emphasizes the European regulatory framework with particular emphasis on the Portuguese context, using the guidelines of Good Clinical Practices (GPC) to ensure alignment with internationally recognized standards. Through lectures, case studies and practical exercises, participants will acquire the necessary skills to conduct clinical trials that comply with ethical and regulatory standards, safeguarding the rights and well-being of participants and data integrity.