???global.info.a_carregar???
Identification

Personal identification

Full name
Dinah Marçal Verdugo Duarte

Citation names

  • Duarte, Dinah

Author identifiers

Ciência ID
381C-ABE6-9ADD
ORCID iD
0000-0002-2595-5263
Education
Degree Classification
2019 - 2019
Concluded
Advanced PhD Courses of the PhD Programme of Medicines and Pharmaceutical Innovation (i3DU) (Curso de doutoramento (conclusão de unidades curriculares))
Major in Non-clinical efficacy and safety
Universidade de Lisboa Faculdade de Farmácia, Portugal
18/20
2019 - 2019
Concluded
Advanced PhD Courses of the PhD Programme of Medicines and Pharmaceutical Innovation (i3DU) (Curso de doutoramento (conclusão de unidades curriculares))
Major in Epidemiology research in drug lifecycle
Universidade de Lisboa Faculdade de Farmácia, Portugal
19/20
2015 - 2015
Concluded
Specialist with recognized experience and professional competence, in the area of Pharmaceutical Sciences, according to Decree-Law 74/2006 (article 3), as amended by Decree-Laws 107/2008, 230/2009 and 115/2013. (Título de especialista)
Major in Pharmaceutical Sciences
Universidade Lusófona, Portugal
2015 - 2015
Concluded
Advanced Program on Pharmaceutical Management (APROPHARMA) (Pós-Graduação)
Major in Pharmaceutical Management
Universidade de Lisboa Faculdade de Farmácia, Portugal
2012 - 2012
Concluded
Training Programme in Public Management (FORGEP) (Pós-Graduação)
Major in Public Management
Direção-Geral da Qualificação dos Trabalhadores em Funções Públicas, Portugal
17/20
2007 - 2007
Concluded
Regulation and Evaluation of Medicines and Health Products (Mestrado)
Major in Pharmacotoxicology
Universidade de Lisboa Faculdade de Farmácia, Portugal
Excellent
2006 - 2006
Concluded
Regulatory Affairs Specialist (Título de especialista)
Major in Regulatory Affairs
Ordem dos Farmaceuticos, Portugal
2006 - 2006
Concluded
Hospital Pharmacy Specialist (Título de especialista)
Major in Hospital Pharmacy
Ordem dos Farmaceuticos, Portugal
1985 - 1991
Concluded
Doctor of Pharmacy Degree (PharmD) (Licenciatura)
Major in Ambulatory and Hospital Pharmacy
Universidade de Lisboa Faculdade de Farmácia, Portugal
15/20
Affiliation

Teaching in Higher Education

Category
Host institution
Employer
2017 - Current Invited Assistant Professor (University Teacher) Universidade de Lisboa Faculdade de Farmácia, Portugal
Universidade de Lisboa Faculdade de Farmácia, Portugal
2000 - Current Assistant Professor (University Teacher) Universidade Lusófona, Portugal
Universidade Lusófona de Humanidades e Tecnologias Escola de Ciências e Tecnologias da Saúde, Portugal

Positions / Appointments

Category
Host institution
Employer
2018 - Current COMP Representative in the EMA’s group “Human Scientific Committees Working Party With Healthcare Professionals Organisations (HCPWP) ”, 2013-2015 (CHMP representative) and COMP representative since 2 Infarmed Autoridade Nacional do Medicamento e Produtos de Saúde IP, Portugal
European Medicines Agency, Netherlands
2015 - Current Non-clinical Assessor at Scientific Evaluation Unit , Directorate for the Evaluation of Medicinal Products Infarmed Autoridade Nacional do Medicamento e Produtos de Saúde IP, Portugal
2015 - Current Committee of Orphan Medicinal Products (COMP) member from Portugal, at European Medicines Agency (EMA), since 2015 Infarmed Autoridade Nacional do Medicamento e Produtos de Saúde IP, Portugal
European Medicines Agency, Netherlands
2013 - Current Expert member at Paediatric Committee (PDCO) “Non-clinical Working Group” (NcWG), since 2013 Infarmed Autoridade Nacional do Medicamento e Produtos de Saúde IP, Portugal
European Medicines Agency, Netherlands
2015 - 2018 COMP Representative in the Steering Group of ENCePP (European Network of Centres for Pharmacoepidemiology & Pharmacovigilance), 2015-2018 Infarmed Autoridade Nacional do Medicamento e Produtos de Saúde IP, Portugal
European Medicines Agency, Netherlands
2011 - 2017 Organic Unit Director Infarmed Autoridade Nacional do Medicamento e Produtos de Saúde IP, Portugal
2012 - 2015 Committee for Medicinal Products for Human Use (CHMP) alternate member from Portugal, at EMA, 2012-2015 Infarmed Autoridade Nacional do Medicamento e Produtos de Saúde IP, Portugal
European Medicines Agency, Netherlands
Outputs

Publications

Book chapter
  1. Duarte, Dinah. "A Regulatory and Safety Perspective on Medical Devices". 1815-1826. {IGI, 2021.
    10.4018/978-1-7998-3479-3.ch125
Journal article
  1. Duarte, Dinah. "Patient Preferences for Multiple Myeloma Treatments: A Multinational Qualitative Study". Frontiers in Medicine 8 (2021): http://dx.doi.org/10.3389/fmed.2021.686165.
    10.3389/fmed.2021.686165
  2. Duarte, Dinah. "Analysis of Medical Device Alerts Issued by the Portuguese Medicines Agency: Scoping the Purpose of New Regulatory Recommendations". Acta Médica Portuguesa 34 3 (2021): 201-201. http://dx.doi.org/10.20344/amp.13419.
    10.20344/amp.13419
  3. Duarte, Dinah. "The translational value of animal models in orphan medicines designations for rare paediatric neurological diseases". Regulatory Toxicology and Pharmacology 118 (2020): 104810-104810. http://dx.doi.org/10.1016/j.yrtph.2020.104810.
    10.1016/j.yrtph.2020.104810
  4. Duarte, Dinah. "Evaluation of Juvenile Animal Studies for Pediatric CNS-Targeted Compounds: A Regulatory Perspective". International Journal of Toxicology (2019): http://dx.doi.org/10.1177/1091581819883569.
    10.1177/1091581819883569
  5. Duarte, Dinah. "Nonclinical data supporting orphan medicinal product designations in the area of rare infectious diseases". Drug Discovery Today (2019): http://dx.doi.org/10.1016/j.drudis.2019.10.015.
    10.1016/j.drudis.2019.10.015
  6. Duarte, Dinah. "Nonclinical data supporting orphan medicinal product designations: lessons from rare neurological conditions". Drug Discovery Today (2018):
    https://doi.org/10.1016/j.drudis.2017.09.015
  7. Duarte, Dinah. "Strengthening standards and collaboration to support medicines evaluation: Ten years of the European Network of Centres for Pharmacoepidemiology and Parmacovigilance (ENCePP)". Pharmacoepidemiology and Drug Safety (2018):
    10.1002/pds.4381
  8. Duarte, Dinah. "An overview of pharmaceutical excipients: safe or not safe?". Journal of Pharmaceutical Sciences (2016):
    10.1016/j.xphs.2016.03.019
  9. Duarte, Dinah. "Rebuttal to Dr. Andrew and Dr. Keller letter to the Editor on “Juvenile Animal Studies in Oncology Medicines for Children”". Reproductive Toxicology (2016):
    10.1016/j.reprotox.2016.05.013
  10. Duarte, Dinah. "Use of Juvenile Animal Studies to Support Oncology Medicine Development in Children". Reproductive Toxicology (2015):
    10.1016/j.reprotox.2015.05.005
  11. Duarte, Dinah. "Juvenile animal studies in the development of pediatric medicines: experience from European medicines and pediatric investigation plans". Birth Defects Research Part B: Developmental and Reproductive Toxicology (2011): http://dx.doi.org/10.1002/bdrb.20299.
    10.1002/bdrb.20299
Activities

Association member

Society Organization name Role
2018 - Current Portuguese Hub from EATRIS-ERIC: European infrastructure for translational medicine - European Research Infrastructure Consortium National Coordinator of the Portuguese Hub from EATRIS-ERIC: European infrastructure for translational medicine - European Research Infrastructure Consortium, since 2018.

Committee member

Activity description
Role
Institution / Organization
2018 - Current Member of the Scientific Committee of Orphanet Portugal (The portal for rare diseases and orphan drugs), since 2018.
Member
Direcção-Geral da Saúde, Portugal
2017 - Current Member of the Portuguese National Commission for Women, Children and Adolescents (Comissão Nacional da Mulher, Criança e Adolescente - CNMCA), from the Directorate-General of Health (Direção Geral de Saúde - DGS) - Despacho nº 4492/2017 de 25 de maio, since 2017
Member
Direcção-Geral da Saúde, Portugal
2016 - 2017 Member of the Technical Monitoring Group of the Portuguese Delegation to the Programmatic Committee of the Societal Challenge (Grupo Técnico de Acompanhamento (GTA) da Delegação Portuguesa ao Comité Programático do Desafio Societal 1 - (DS1) from Horizon 2020 (H2020) - “ Health, Demographic Change and Welfare”, 2016-2017
Member
Fundação para a Ciência e a Tecnologia, Portugal
2013 - 2016 Member of the Coordinating Committee for the Treatment of Lysosomal Storage Disorders (Comissão da Comissão Coordenadora do Tratamento das Doenças Lisossomais de Sobrecarga - CCTDLS), of the National Institute of Public Health (INSA), Ministry of Health, 2013-2016
Member
Instituto Nacional de Saúde Doutor Ricardo Jorge, Portugal

Evaluation committee

Activity description
Role
Institution / Organization Funding entity
2016 - Current Member of the Portuguese scientific Evaluation Board of Medicines (Comissão de Avaliação de Medicamentos – CAM) of the Portuguese National Authority of Medicines and Health Products - INFARMED, I.P., Despacho nº 13120/2016 de 2 de novembro, since 2016
Evaluator
Infarmed Autoridade Nacional do Medicamento e Produtos de Saúde IP, Portugal
2013 - 2014 Member of the Portuguese Pharmacopeia Commission (Comissão da Farmacopeia Portuguesa) of the Portuguese National Authority of Medicines and Health Products - INFARMED, I.P., 2013-2014.
Evaluator
Infarmed Autoridade Nacional do Medicamento e Produtos de Saúde IP, Portugal