Estágio em assuntos regulamentares e farmacovigilância na BlueClinical

• Main Author: Barbosa, Manuel Boloto
• Publication Date: 2025
• Format: Master thesis
• Language: eng
• Source: Repositórios Científicos de Acesso Aberto de Portugal (RCAAP)
• Download full: http://hdl.handle.net/10362/179240
• topic: Clinical Research; Clinical Trials; Regulatory Affairs; Pharmacovigilance; Regulation; Commercial Confidential Information; Transparency; Saúde

Abstract: Clinical Research is conducted on either sick or healthy volunteers to stimulate innovation, to improve patient care and enhancement of public health. Clinical Trials are essential for testing the safety and efficacy of new treatments in healthcare. The Clinical Trials Regulation (EU) No 536/2014 came into effect on January 31st, 2022, and it governs Clinical Trials on medicinal products in the European Union and the European Economic Area. It introduced a new framework for the submission and supervision of Clinical Trials and harmonized the conduct of Clinical Trials across the Member States. One of the main objectives of the Regulation is to promote transparency in the sector. Information and essential documentation generated during trial lifecycle will be available in the public domain. One of the exceptions for disclosure is to protect Commercial Confidential Information. Therefore, the Regulation balances scientific advancement and the legitimate commercial interests of Sponsors that invest in the Clinical Trial. This internship report was developed as part of the Master’s Degree in Clinical Research Management and is divided into two sections. The first includes a literary review going over the submission process of Clinical Trials, as well as the transparency requirements and the protection of Commercial Confidential Information. The second section describes the activities performed during the internship in the department of Regulatory Affairs and Pharmacovigilance of the company BlueClinical - Investigação E Desenvolvimento Em Saúde, Lda. The experience cultivated key professional and personal skills and provided a close contact with Clinical Research.