Regulação do Medicamento e Dispositivos Médicos

Objectives

The curricular unit will allow students to understand how the translational process of getting medicinal products and medical devices from research to the market is implemented, under a regulated environment, according to European, North-American and global (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)) rules. After the training program students will be able to design strategies on how to transfer knowledge to the market in these areas, under a highly regulated environment, allowing to better design research and the lab to market transfer process.

Syllabus

1.General overview of regulation in Healthcare. 2.Regulatory structure for the European and north-american procedures for market access of medicinal products (biotech drugs & Advanced Therapy Medicinal Products (ATMPs)) and medical devices. 3.Regulatory standards for the translational research of medicinal products, with particular detail on biotech products. 4.Regulatory standards for the translational research of medicinal products, with particular detail on ATMPs. 5.Orphan medicines and role of regulatory scientific advise. 6.Regulation of medical devices. 7.Global harmonization of health technologies innovation. 8.Clinical research and regulatory compliance. 9.Critical examples for translational research and the issues on regulation of hybrid systems. 10.Risk management and pharmacovigilance systems. 11.Global trends in regulatory science development. 12.Quality Management Systems under regulatory supervision (GMPs, GLPs, GCPs). 13.Roundtable with specialists.

Prerequisites

No specific prerequisites other than a general comprehension on the technologies used for the development of medicinal products and medical devices.

Cross Competence Component

Important soft skills will be developed within the UC content, in order to understand the research to business translation process including an updated view on the companies development and business models, performed un der a regulatory environment.

Laboratorial Component

No experimental setting. Demonstration work will be done using workshop sessions to discuss alternatives within a set of examples used as training module.

Programming And Computing Component

No programming and computing components outside of the use of digital platforms for regulatory purpose, as set by the regulatory agencies.

Ethical Principles

All members of a group are responsible for the group’s work In any assessment every student shall honestly disclose any help received and sources used. In an oral assessment, every student shall be alble to present and answer questions about the entire assignment and solution.