Sumários
Group Work
26 Setembro 2025, 18:00 • Rui dos Santos Ivo
Presentation of group projects on different topics, following prior distribution and discussion of selected articles related to themes covered in previous sessions.
Pharmacovigilance; Inspection-related procedures and obligations
25 Setembro 2025, 18:00 • Rui dos Santos Ivo
Overview of pharmacovigilance EU and national frameworks. Practical exercise on the submission of an adverse reaction case on the RAM Portal and analysis of a safety signal.
Principles and practices for inspections, ensuring adherence to regulatory guidelines and GxP. Obligations for Marketing Authorization Holders (MAs) and distributors to control manufacturing and supply under regulatory oversight (FDA, EMA) to guarantee product quality and safety
Regulation of the Clinical use of Psychedelics; Advertising and Information on Medicinal Products
20 Setembro 2025, 14:00 • Rui dos Santos Ivo
Overview of emerging legislation and ethical considerations for psychedelic-assisted therapies, including clinical research requirements and safety standards.
Regulatory principles governing promotion, advertising, and dissemination of information on medicines, ensuring compliance with national law.
Phage Therapy Regulation and Medical Cannabis Regulation
20 Setembro 2025, 09:00 • Rui dos Santos Ivo
Overview of regulatory frameworks and scientific considerations for bacteriophage-based therapies, including the national approach on phage therapy regulation.
Key principles governing medical cannabis use, authorisation pathways, quality standards, and policy challenges within the international and national contexts.
Regulation of Orphan Medicines and Advanced Therapy Medicinal Products
19 Setembro 2025, 18:00 • Rui dos Santos Ivo
Overview of prevalence and public health impact of rare diseases and specific EU legal and regulatory frameworks and pathways for orphan medicines.