Mónica Sánchez Castañeda

Led protocol registration and implementation for NIH-funded HIV and respiratory virus studies within the INSIGHT network, managing multi-center enrollment, timelines, and quality improvement initiatives that ensured regulatory adherence and timely delivery.

Coordinated pharmaceutical operations and regulatory compliance for international clinical trials across Peru, establishing IP management and quality control processes that resulted in zero protocol deviations related to investigational product handling.

Managed regulatory documentation and local submissions for clinical studies, preparing materials for IRB, INS and DIGEMID to support study start-up and compliance activities.

Coordinated pharmaceutical activities across Peru and Ecuador for the iPrEx study, supporting investigational product management that contributed to pivotal data for FDA approval of PrEP.

Coordinated pharmaceutical activities across multiple Peruvian and Ecuadorian sites, preparing documentation for DAIDS/PAB review and ensuring harmonized processes and regulatory compliance.

Managed retail pharmacy operations including regulatory liaison with DIGEMID, inventory control systems, and quality assurance processes to maintain compliance and operational efficiency.

Implemented an Alternative Medicine area and led efficacy, safety, and cost-analysis studies on nutritional supplements, establishing databases and evidence for product decisions.

Completed a degree program in Pharmacy and Biochemistry at Universidad Nacional Mayor de San Marcos from 1990 to 1997.