Sumários

Aspects of Administrative, Health and Pharmaceutical Legislation

18 Setembro 2025, 18:00 • Rui dos Santos Ivo

Overview of administrative law principles and the right to health within the framework of EU and national legislation.

Key legal foundations governing medicinal products regulation and interaction with health policies

New methodological and regulatory trends for the evaluation and MA of medicinal products; Clinical, regulatory and ethical aspects of clinical research

13 Setembro 2025, 14:00 • Rui dos Santos Ivo

Overview of emerging approaches in regulatory science and activities; EU frameworks and regulatory pathways and mechanisms for the scientific evaluation of centralised marketing authorisation applications (MAA). Perspective on the role of the CHMP.

Key principles and requirements for clinical trials, including ethical standards and regulatory and compliance aspects. Overview of the EU clinical trial legislation and Good Clinical Practices (GCP) and the Declaration of Helsinki. Presentation on the Accelerating Clinical Trials in the EU (ACT EU) objectives and actions. Brief perspective on combined studies.

Evaluation and marketing authorisation of medicinal products for human use

13 Setembro 2025, 09:00 • Rui dos Santos Ivo

Overview of the regulatory process for evaluating quality, safety, and efficacy, leading to marketing authorisation (MA).

Principles and fundamentals of the scientific evaluation of centralised including key steps.

Introduction to Medicines Regulation and European Regulatory System for Medicines

12 Setembro 2025, 18:00 • Rui dos Santos Ivo

Introduction to key concepts of regulation and an overview of regulatory mechanisms and practices, including the presentation of the Good Regulation Principles.

Historical development and evolution of the European Regulatory System for Medicines and the role of regulatory authorities and functioning of the European medicines regulatory network (EMA, HMA, ICMRA, ICH and other key-structures)