Implementação de inteligência artificial responsável na indústria farmacêutica

Resumo

The research addresses the responsible implementation of artificial intelligence (AI) in the pharmaceutical industry, taking into account the sector’s specificities. Although there is international consensus on the need to ensure transparency, human oversight, bias mitigation, data protection, and accountability, applying these principles in this industry requires sector-specific governance structures. The study shows that the challenges do not stem from a lack of ethical reference frameworks, but rather from the need to align AI systems with stringent regulatory regimes focused on patient safety. AI is embedded at different stages of the pharmaceutical value chain – from research to pharmacovigilance – assuming varying levels of risk and regulatory requirements, which calls for proportional and context-sensitive governance. Overall, the work concludes that responsible AI governance should be understood as an integrated institutional process, bringing together ethical principles, organizational frameworks, regulatory requirements, and operational practices, in which corporate legal functions play a structuring role as a coordinating element among different areas and organizational rationalities. By providing a sector-specific analysis and proposing inputs for governance programs compatible with the complexity and risks of the pharmaceutical industry, the research contributes to the broader debate on pathways toward building responsible AI.

Ficha do documento

Tipo

Dissertação

Ano

2026

Instituição

Fundação Getulio Vargas

Fonte

Repositório da FGV

Idioma

Português

Acesso

Acesso aberto

Identificador

oai:repositorio.fgv.br:10438/39379

Temas

Desenvolvimento EconômicoTecnologiaGovernança

Palavras-chave

Inteligência artificialIndústria farmacêuticaGovernança de IAGestão de riscosÉticaConformidadeArtificial intelligencePharmaceutical industryAI governanceRisk managementEthics and complianceDireitoIndústria farmacêutica - Inovações tecnológicasInteligência artificial - Aspectos morais e éticosTecnologia e direitoGovernança