Shiva Kumar Revoori

Manager - Clinical Research @Apotex Inc.

IN

Responsible for the Protocol management process including the coordination with IEC, ensures required regulatory documentation is in place as per the applicable jurisdictions. Responsible for conducting, monitoring and reporting of Bioequivalence Trials as per the different regulatory requirements and the established systems (viz. ANVISA, MHRA, MCC, USFDA). Developing the protocols, CRF’s, SOP’s and systems for the conducting of the Bioequivalence Trials. Responsible for preparation of the clinical and Study reports as per the different regulatory requirements. Conducting training of staff on GCP, SOP and study related activities, responding to the quires raised by the Quality Assurance department and responsible for responding to the Regulatory deficiencies.

Birla Institute of Technology and Science, Pilani

M.Pharm

Kakatiya University

B.Pharmacy