This is a short massive open online course (MOOC) that hopes to give you an overview of Regulation in Health Technologies. Being a partnership between the engineering and pharmacy schools of the University of Lisbon and benefiting from the participation of experts working in the industry, regulatory agencies and academy, this MOOC introduces participants to key concepts and methods, hot topics, and current challenges on the regulation of diverse and emerging health technologies and products. This MOOC is funded by EIT Health and enables participants to have an introductory exploration of this multidisciplinary area. We hope you enjoy it!
This MOOC is divided into five modules:
The first module introduces regulation in health, precisely what it is and why it is needed. It will also give an overview of the legal framework in the EU and a comparison with other agencies. The second module will dive deeper into the regulation of different types of medicinal products: ATMPs, medical devices, data and software health technologies. In the third module, clinical research and regulatory compliance will be approached, as well as the role of evidence-based medicine. Plus, the risk management and vigilance systems will be detailed. Additionally, the role of information systems will be discussed. In the fourth module, health technology evaluation will be studied from its definition and different stages to its theoretical principles and methods for economic evaluation. Finally, in the fifth module, global trends in regulatory science development are shown and a discussion of different health technologies from an ethical standpoint.
Anyone interested in the topic, no background knowledge required.
End of registration: 11 December 2023
Course start date: 15 December 2023
Course end date: 15 March 2024
Professor in Decision Sciences at the Engineering and Management Department of IST, and a researcher at the Centre for Management Studies and the Institute of Biomedical Science of Técnico. Coordinates the health network of the University of Lisbon and the Decision Science and Management Engineering group of the Centre of Management Studies.
Head of the Department of Pharmacological Sciences. Pharmacology, Pharmacotoxicology and Regulatory Science Professor at the University of Lisbon and a non-clinical and regulatory science expert at the Portuguese agency, Infarmed and EMA.
Assistant Professor at IST and a Researcher at the Centre for Management Studies of Instituto Superior Técnico.
In addition to the coordinators, this course had contributions from: Cláudia Lobato da Silva, Associate Professor at the Department of Bioengineering; Lígia Figueiredo, R&D Manager of Bioceramed; Hélder Mota-Felipe, President of the Order of Pharmacists; Paulo Nicola, medical doctor and professor at the Engineering and Management Department; Carla Torre, Epidemiology/Pharmacoepidemiology Assessor for the Medicines Evaluation Committee at Infarmed; Paula Barão Ferreira, invited assistant professor in the Department of Pharmacy, Pharmacology and Health Technologies at the Faculty of Pharmacy of the University of Lisbon (FFUL); Bruno Sepodes, Full Professor of Pharmacological Sciences at FFUL; Mário Silva, Full Professor of Information Systems at IST; Márcia Silva, Head of the pharmacovigilance department at INFARMED; Raquel Alves, Head of Medical Devices Vigilance Unit at INFARMED; Francisco Viterbo, PhD student at the Engineering and Management Department; Ana Matoso, PhD student at Institute of Systems and Robotics.
_________Este é um curso online (MOOC) pretende dar uma visão geral da Regulação em Tecnologias da Saúde. Sendo uma parceria entre as escolas de engenharia e farmácia da Universidade de Lisboa e beneficiando da participação de especialistas que trabalham na indústria, nas agências reguladoras e na academia, este MOOC introduz os participantes a conceitos e métodos chave, “hot topics” e desafios actuais na regulação das diversas e emergentes tecnologias e produtos de saúde. Este MOOC é financiado pelo EIT Health e permite aos participantes uma exploração introdutória desta área multidisciplinar. Esperamos que gostem!
Este MOOC está dividido em cinco módulos::
O primeiro módulo apresenta a regulamentação no domínio da saúde, o que é exatamente e porque é necessária. Apresentará também uma panorâmica do quadro jurídico na UE e uma comparação com outras agências. O segundo módulo aprofundará a regulamentação dos diferentes tipos de medicamentos: ATMPs, dispositivos médicos, tecnologias de saúde de dados e software. No terceiro módulo, será abordada a investigação clínica e a conformidade regulamentar, bem como o papel da medicina baseada em evidência. Além disso, serão pormenorizados os sistemas de gestão do risco e de vigilância. Para além disso, será discutido o papel dos sistemas de informação. No quarto módulo, a avaliação das tecnologias da saúde será estudada desde a sua definição e diferentes etapas até aos seus princípios teóricos e métodos de avaliação económica. Finalmente, no quinto módulo, são apresentadas as tendências globais no desenvolvimento da ciência regulamentar e uma discussão sobre as diferentes tecnologias da saúde do ponto de vista ético.
Qualquer pessoa interessada no tema, sem necessidade de conhecimentos prévios.
Data de fim de inscrições: 11 de dezembro de 2023
Data de início do curso: 15 de dezembro 2023
Data de fim do curso: 15 de março de 2024
The following course and its contents are licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.