Do Ensaio Clínico ao Acesso Terapêutico (Fmul)

Objectives

Knowledge of the drug life cycle is essential for rational prescribing and for the training of physicians and technicians as future experts in the evaluation of therapeutic innovation. In this context, this curricular unit (UC) has the following general objectives: - Knowledge of the Drug Cycle: from clinical trials to pharmacovigilance; - Basic notions of pharmacotherapeutic and pharmacoeconomic evaluation procedures. To promote the acquisition of knowledge about the process of evaluation and approval of drugs and medical devices, from a scientific, formal, and legal point of view, the CU has the following specific objectives: - Describe the drug cycle and health technologies; - State the clinical and regulatory aspects of clinical trials; - Describe the therapeutic evaluation prior to market introduction; - Specify the pharmacotherapeutic and pharmacoeconomic evaluation models for financing; - Evaluate the safety criteria of drugs and devices.

Syllabus

The drug cycle and health technologies; Clinical and regulatory aspects of clinical trials; Therapeutic evaluation prior to market introduction; Pharmacotherapeutic and pharmacoeconomic evaluation for funding; Security assessment.