Daniela Da Silva Email & Phone Number

Amsterdam, North Holland, Netherlands

Amsterdam Area, Netherlands

Londres, Reino Unido

Human Medicines Evaluation Division - Scientific and Regulatory Management Department -Rheumatology, Respiratory, Gastroenterology and Immunology OfficeScientific Administrator for the Rheumatology and Immunology Working Party - Provide direct support and input to the Rapporteurs and the Committee for Medicinal Products for Human Use (CHMP) on the regulatory science aspects of the application dossiers for marketing authorizations, ensuring robust benefit/risk assessments and enabling consistency and coherence between outputs .- Review of the scientific overview, non-clinical, clinical and benefit-risk balance sections of Assessment Reports (AR) for Marketing Authorization Applications both in pre- and postauthorizationphase.- Conducting pre-submission meetings and peer-reviews.- In post-authorisation, lead product team member, for all line extensions and extension of indication procedures. - Coordination of the product team.- Support to the scientific work of the committees at the plenary including the Committee for Medicinal Products for Human Use (CHMP), Pharmacovigilance Risk Assessment Committee (PRAC) and Committee for Advanced Therapies (CAT).- Provide support and guidance to the applicants from a scientific and regulatory point of view in the context of the Marketing Authorization. Liaise with applicants in all scientific content related matters.- Contribution to the development activities and knowledge transfer from development intoevaluation, including business pipeline meetings.- Scientific Secretariat for the RIWP: coordination of TC and face to face meetings; development of the working plan; support to the WP on the development and finalization of guidelines; coordination and facilitation of the interaction between the working party and the different committees or other working groups including contribution on relevant rheumatology and immunology aspects to Scientific Advice and protocol assistance.

Londres, Reino Unido

Human Medicines Evaluation Division - Scientific and Regulatory Management Department - Oncolgy, Hematology and Diagnostics OfficeScientific Administrator for the Biosimilar Medicinal Products Working Party- Provide direct support and input to the Rapporteurs and the Committee for Medicinal Products for Human Use (CHMP) on the regulatory science aspects of the application dossiers for marketing authorizations, ensuring robust benefit/risk assessments and enabling consistency and coherence between outputs .- Review of the scientific overview, non-clinical, clinical and benefit-risk balance sections of Assessment Reports (AR) for Marketing Authorization Applications both in pre- and postauthorizationphase.- Conducting pre-submission meetings and peer-reviews.- In post-authorisation, lead product team member, for all line extensions and extension of indication procedures. - Coordination of the product team.- Support to the scientific work of the committees at the plenary including the Committee for Medicinal Products for Human Use (CHMP), Pharmacovigilance Risk Assessment Committee (PRAC) and Committee for Advanced Therapies (CAT).- Provide support and guidance to the applicants from a scientific and regulatory point of view in the context of the Marketing Authorization. Liaise with applicants in all scientific content related matters.- Contribution to the development activities and knowledge transfer from development intoevaluation, including business pipeline meetings.- Scientific Secretariat for the BMWP: coordination of TC and face to face meetings; development of the working plan; support to the working party on the development and finalization of guidelines; coordination and facilitation of the interaction between the working party and the different committees or other working groups; systematic review of all the Biosimilar Scientific Advice procedures; coordination of cluster meetings with International regulators (FDA, PMDA, TGA and HC).

Human Medicines Evaluation Division - Scientific and Regulatory Management Department - Endocrinology, Cardiovascular and Metabolism - Support to the scientific assessment of different procedures over the life-cycle of Endocrinology, Metabolism and Cardiovascular medicinal products including but not restricted to Assessment Reports and SmPCs.- Development and coordination of parts of a project related with Risk Minimization Plans and Effectiveness of Risk Minimization Measures (published article).- Coordinating the development of diabetes products databases.- Review and analysis of Scientific Advice procedures for Endocrinology, Cardiovascular and Metabolism medicinal products.- Main coordinator for the organization of a multi-stakeholder (including Pharmaceutical Industry, International regulators and Patient representatives) workshop on the role of pharmacokinetic and pharmacodynamic measurements in the use of direct oral anticoagulants (DOACs). This comprised of scientific input into the development of the agenda, background research, selection of speakers and scientific secretariat support.

Human Medicines Evaluation Division - Scientific and Regulatory Management Department - Endocrinology, Cardiovascular and Metabolism

Mafra

- Customer service, including advice on the proper use and storage of medicines- Order management - Validation/verification of prescriptions- Billing- Pharmaceutical services, including measurement of biochemical parameters

Master'S Degree, Pharmaceutical Sciences

Pharmaceutical Sciences