Sumários

European HTA Regulation and the European Health Technology Assessment System

14 Novembro 2025, 18:00 Rui dos Santos Ivo

Overview of the European HTA Regulation and the European Health Technology Assessment System (context and background). European-Level Cooperation in HTA (EU-HTA) and integration of perspectives of regulators, HTA bodies and payers. INFARMED's approach to aligning evaluation and decision-making processes.


(1) Managing the Availability of Medicines (2) Strategies for Rational Use of Medicines

13 Novembro 2025, 18:30 Rui dos Santos Ivo

Managing the Availability of Medicines
EU and national frameworks to prevent and mitigate medicine shortages and ensure continuous and security of supply. Concepts and defintions


Strategies for Rational Use of Medicines
Overview of local interventions and policy approaches to promote appropriate prescribing, dispensing and use of health technologies. Medicines positioning and the role of the National and Local Pharmaceutical and Therapeutics Committees


From Marketing Authorisation to Financing Decision

8 Novembro 2025, 14:00 Rui dos Santos Ivo


Health Systems and Policies

8 Novembro 2025, 09:00 Rui dos Santos Ivo

Introduction to structures, health systems models, and policy frameworks shaping healthcare delivery, including an overview of the Portuguese National Health Service (SNS). Core principles on public policy implementation within the health sector


(1) From Clinical Trials to Therapeutic Access: new challenges and trends; (2) Digital Health Fundamentals and DTx principles and regulation

7 Novembro 2025, 18:00 Rui dos Santos Ivo

(1) From Clinical Trials to Therapeutic Access
Presentation and discussion on challenges and trends: adaptive trials, utilisation of real-world evidence in regulatory decision-making, regulatory pathways and strategies for equitable access.
(2) Digital Health & Digital Therapeutics (DTx)
Introduction to definitions and key concepts, with perspectives on integration into healthcare delivery and health policies, including fundamentals, clinical validation, and regulatory frameworks.