Vipasha Bhatt

Tätig als PRRC mit Verantwortung für die Qualitätsüberwachung gemäß EU-Vorgaben. Sicherstellung und Pflege eines umfassenden Qualitäts- und Dokumentationsmanagementsystems. Mitarbeit beim Einfuhrverfahren für Amoxicillin-Trockensaft aus Indien inkl. Dokumentenerstellung. Abstimmung mit Herstellern, Zollagenten, Laboren und dem Regierungspräsidium für Prüfungen und GDP-Inspektionen.

* Preparation, implementation, follow-up of Site initiation and monitoring visits as part of the clinical study. * Assessing the quality and integrity of site practices. * Source data verification and writing monitoring reports. * Projects: GeparDouze, GeparPippa, Sascia, Destiny, Olympia. * Software: Medcodes, Marvin, Raves/ Medidata.

*Preparation of clinical summary and study reports as per regulatory requirements. *Performing study/screening activities of volunteers, ICF presentation, supervising study activities, check-in and check- out of subjects, dosing activity, segregation, preparation of Trial Mater File and verification of study documents for completeness and correctness.

*Report preparation (Pivotal-Pilot Study reports, Method validation Report, Amendments, Canadian and WHO reports) as per the regulatory bodies like USFDA, EU, ANVISA, DCGI *Production of high-quality subsequent documents like ECTD as per Regulatory submission and compiled regulatory documents *Data Interpretation in clear and accurate manner with WATSON LIMS Software

Also did a certificate course in Regulatory Affairs