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The learning outcomes aim to understand the objectives and components of the regulation of medicinal products and healthcare products, the different regulatory options and practices, in the context of a global framework of principles and practices of regulation and the corresponding legal framework. Its aimed at reinforcing the knowledge of this specific type of regulation, providing an overview of the different areas, such as research, evaluation, authorisation, vigilance, control, utilisation of medicines and health products. Moreover all the aspects pertaining to the economical regulation of medicines and healthcare products will be covered. It is also intended to provide a clear understanding of the institutional governance framework, both at European and National level, considering the different type of responsibilities and how and where they are exercised. Writing essays or analysing published articles, students will apply the regulatory principles and methodologies.
The Regulation of Medicinal Products and the Evolution of the Regulatory System: regulatory concepts and tools, phases of the system and institutions involved.
Characterisation of the regulatory authorities, with particular emphasis on the EMA and INFARMED.
Relation of the regulatory system with the health system and the Portuguese legal system, with references to administrative law, health law and European Union law.
Main elements of the regulatory system, with special focus on the evaluation and authorisation procedures, inspection and pharmacovigilance.
The farmaco-economical regulation and the main regulatory components of the pricing system and the reimbursement system of medicinal products. Reference and evidence of the main characteristics of the regulation of healthcare products.
Current developments and perspectives at EU level.