Fernanda Carolina Ramos Dos Santos Email & Phone Number

São Paulo, Brasil

São Paulo, Brasil

• In charge of study documentation development (protocols, case report forms and reports);• Experience in site monitoring for different linds of clinical trials: Target Animal Safety, Efficacy (antimicrobial, anti-inflammatory, parasiticide), Residues (tissue and milk) and Pharmacokinetic, following known guidelines such as VICH, EMA, W.A.A.V.P., CODEX, FDA and local legislation for the Latin America region.• Involved in studies of the following domestic species: dogs, cats, cattle, horses and swine.• Involved in studies for local and international product registration.• Structured strong partnership with the main CROs in Brazil;• Integration with teams from different areas (Pharmacovigillance, Legal, Financial and Regulatory areas, including support ofdossier preparation).• Responsible for quotations, price and deadline negotiation with CROs.• Support on budget and contracts management;• Discussion with laboratories about analytical validation for the determination of drug residues in tissue, milk and plasma, and evaluation of analytical results.• Calculation of withdrawal period in edible tissues and milk with EMA software.• Provide training of Good Clinical Practices for CROs teams.• In charge of the documentation to be presented to the Ministry of Science, Technology, and Innovation (MCTI) to apply for tax benefits under the tax incentive program for innovation in Brazil ("Lei do Bem").

São Paulo E Região, Brasil

• In charge of study documentation development (protocols, case report forms and reports);• Experience in site monitoring for different linds of clinical trials: Target Animal Safety, Efficacy (antimicrobial, anti-inflammatory, parasiticide), Residues (tissue and milk) and Pharmacokinetic, following known guidelines such as VICH, EMA, W.A.A.V.P., CODEX, FDA and local legislation for the Latin America region.• Involved in studies of the following domestic species: dogs, cats, cattle, horses and swine.• Involved in studies for local and international product registration.• Structured strong partnership with the main CROs in Brazil;• Integration with teams from different areas (Pharmacovigillance, Legal, Financial and Regulatory areas, including support ofdossier preparation).• Responsible for quotations, price and deadline negotiation with CROs.• Budget and contracts management;• Discussion with laboratories about analytical validation for the determination of drug residues in tissue, milk and plasma, and evaluation of analytical results.• Calculation of withdrawal period in edible tissues and milk with EMA software.• Provide training of Good Clinical Practices for CROs teams.

São Paulo E Região, Brasil

Research and development of pharma veterinary products based on good clinical practices; development of protocols and experimental study design; preparation of technical reports; statistical analysis of studies; carrying out clinical study monitoring. Completion of 40 studies, including in vitro efficacy, in vivo efficacy, bioavailability in tissue, safety and withdrawal period determination.

São Paulo E Região, Brasil

Mestrado, Clínica Veterinária

Gestão De Projetos

Medicina Veterinária

Ensino Médio

Técnico Em Informática