Antonieta Lucas
Experiência Profissional
Mais de 25 anos a trabalhar no setor da Saúde, na área dos Produtos de Saúde, mais especificamente em Tecnologias da Saúde onde estão incluídos os Dispositivos Médicos, também na área do Medicamento - Preços e Comparticipações, – HTA, Acesso ao Mercado e Concursos Públicos.
Desde finais de 2015 mais dedicada a Assuntos Regulamentares Europeus, nomeadamente Política e Inteligência Regulamentar. Acompanhamento de forma particular o Regulamento de Dispositivos Médicos (EU)2017/745 de 5 de Abril de 2017.
2021 - present
Associate Director, EMEA Regulatory Policy and Intelligence
Ensure compliance with applicable regulations and standards.
Advocacy activities to support enterprise priorities on regulatory policy and intelligence
- MDCG Working Groups: CIE - Clinical Investigation Evaluation, EUDAMED Clinical Investigation and Post Market Surveillance Group
2016 – 2020
Manager, Regulatory Affairs & EMEA RA Policy
Lead local Regulatory Affairs Department.
Advocacy activities to support enterprise priorities on regulatory policy and intelligence, EMEA
- MDCG Working Groups: CIE - Clinical Investigation Evaluation, EUDAMED Clinical Investigation and Post Market Surveillance Group
In this group we build the Guidance for the MDR – Medical Devices Regulation CI &PS
2013- 2016
Manager, Regulatory Affairs
Lead all the National Regulatory Affairs Responsibility including Clinical Trials local submissions and Approvals
Trade Associations Alcon Representation.
Price and Reimbursement. Governmental Affairs. Alcon’s Institutional representation in external engagement activities.
2007-2013
Regulatory Affairs Manager and Technical Director and Office Manager
Lead Regulatory Affairs department
Clinical trials submissions and approvals, regulatory submissions and approvals
QMS – Quality Representative for ISO 13485 Certification
Pharmacovigilance Responsible
Price and Reimbursement applications, HTA and Market Access
Office manager of Alcon Portugal
1994-2007
Regulatory Affairs Manager and Technical Director
Same as above except for Office Management
1993-1994
Regulatory Affairs Manager at Boehringer Ingelheim
Only dedicated to Medicines Regulatory Affairs and Prices and Reimbursement. Country responsibility
1988-1993
Technical Manager and Regulatory Affairs Manager of Coopers (Wellcome & ICI group)
Regulatory Affairs Responsible and Technical Direction of the distribution warehouse