09h30 – 11h00
Católica Medical School
To access the Open Lecture online, you can use this link
If you would like to attend in person, please let us know by email - with the subject Open Lecture Registration
Within the framework of the Health Law course, an Open Lecture will be held dedicated to the legal, regulatory, and ethical framework of clinical research in Portugal.
The session will address the topic:
“Clinical Research Law (Law no. 21/2014) and INFARMED”, taking into account the recent legislative developments introduced by Law no. 9/2026, of 6 March, which revokes the previous legal regime governing medicinal clinical trials.
This lecture is part of the course’s educational pathway and aims to provide students and the academic community with a solid understanding of how the clinical research system operates, as well as the role of competent authorities in ensuring scientific quality, participant safety, and research integrity.
The intervention will address:
- the role of INFARMED – National Authority of Medicines and Health Products within the clinical research system;
- the regulatory pathway of clinical trials, from submission to authorization;
- the main ethical, regulatory, and clinical challenges associated with conducting health research.
Guest Speaker Dr. Raquel Sofia Faustino Silva Graduate in Pharmaceutical Sciences and Coordinator of the Support Office of the Ethics Committee for Clinical Research (CEIC). She has more than 15 years of experience in the field of ethics and regulation of clinical research. She has completed several training programs in Health Law and Bioethics and is currently pursuing a Law degree.
Moderation:
Mara de Sousa Freitas, Coordinator of the Health Law Course
Free entry | Open to the academic community
This Open Lecture aims to bring students closer to the legal, regulatory, and ethical framework of clinical research, fostering an understanding of the mechanisms that ensure scientific quality, participant protection, and integrity in health research.
