Ezequiel Blanco Email & Phone Number

Buenos Aires, Caba, Ar

Estados Unidos

Av Cordoba 2351, Buenos Aires, Argentina

Gestión de muestras, procesamiento y validación. Contacto y enfoque multidisciplinario. Laboratorio de Guardia y Terapia Intensiva.

Gran Buenos Aires, Argentina

Ciudad Autónoma De Buenos Aires

Guardia de 24hs. Servicio de bacteriología. Muestras: respiratorias, heridas, hemocultivos, coprocultivos y urocultivos. Manejo de aparato automizado Phoenix BD y sistema informático Next lab

Argentina

1. Sites, sponsors, brokers, and regulatory agencies contact in order to obtain documentation required for regulatory submission/ import process of clinical studies.2. Study dossiers (including import/ export) preparation and review for the study submission to regulatory bodies.3. Regulatory status follow-up along with sites and regulatory agencies, to obtain submission, pending or approval letters (including import/ export). Responsible for keeping the status tracking with the provided information for sponsor reporting purposes.4. Communicate with sites and Sponsors to prepare answers to questions issued by the regulatory bodies.5. Periodic reports to MoH submission and follow up, if necessary/ applicable.6. Study supplies management assistance, ensuring the quality of storage, sites shipment, return and destruction.7. Keep the study TMF updated (physical and electronic) in the regulatory sections and complete the Regulatory Tracker.8. Serious Adverse Events (SAE)s reporting to MoH.9. Assist the Regulatory and Logistic Manager (RLM) in the administrative tasks related to studies under his/her responsibilities, in relation to regulatory planning and conduction in accordance with GCP-ICH, Brazilian Regulatory requirements and SOP standards.10. Assist in the revision of the SOPs related to the department activities.11. Provide local regulation trainings to Intrials staff with the Regulatory Affairs and Logistics Manager support. 12. Participate in local or international meetings/courses, aiming to improve knowledge.13. Communicate with Latin America team (collection of docs, information, guidelines on regulations, etc).14. Complete handover to clinical team after initial regulatory submission and approvals are terminated.15. For post-trial programs, perform importation of drugs, initial and follow up submissions to ANVISA. 16. Management of IP stored at Depot with the Team Depot (vendor), RLM and PM, if applicable.

Buenos Aires, Provincia De Buenos Aires, Argentina

eCTD submissions for FDA, HC, EMA and CESP.Submissions through Liquent software.Office excellence. Communication with Sponsors, Reg Ops and multiple areas within PAREXEL.

Argentina

HPLC Agilent, Citrix, StarLIMS, raw material, water analyses, spectroscopy UV, IR and AA

Isidro Casanova, Buenos Aires, Argentina

Thames 327, Villa Crespo Caba

Control de esterilidades, control higiénico de material de empaque, control de aguas, controles higiénicos de productos no necesariamente estériles, ensayo LAL de endotoxinas por método gel-clot, monitoreos ambientales,

Caba

Especialización, Biotecnología Bioquíquimico Farmacéutica, Desarrollo, Validación Y Qc De Productos Biofarmaceuticos

Bioquimico, Biochemistry, 6.89

Bioquimico con orientación en Microbiologia

Bachiller En Economia Y Admnistración, Economía, Promedio 8

Activities and Societies: Equipo de Voley y Natación