Open Lecture | Clinical Research Law

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 6th 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.

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!