PRATHEEP VENKATESAN

Following asper ICH and GCP E6 -R3

Profound knowledge of GCP/ICH guidelines and FDA regulations.

• Clinical Data Management
• Maintained accurate database of research results for future reference and analysis.
• Reviewed, analyzed and interpreted clinical data to identify trends in patient care.
• Ensured 100% compliance of clinical trials with FDA regulations
• Regulatory Affairs
• CDSO , FDA, TGA, EMA.
• Pharmacovigilance
• Aggregate reporting , narrative writing , MedDRA
• Medical writing
• Regulatory document and protocol .
• IB , CSR, CTD
• Attended meetings and reported on activities and resolutions.
• Presented reports from training sessions and workshops attended.
• Collaborated with members of other groups in the company.

Responsibilities to perform and presentation

EP 5.3 chapter Excel sheet validation (Statistics)

ASTM E2315 - "Standard Guide for Assessment of Antimicrobial Activity Using a Time-Kill Procedure

USP 81 BIO Assay

Software Used

LIMS (Lab vantage)

Track wise

Presentation and customer

Time to time response to the our customer

Method development protocol and Report

Method validation Protocol and report

Method transfer protocol and Report

Following asper GLP , GMP ,BP, USP, EP, IP and client method

Antibiotic assay USP 81, Antimicrobial Effectiveness test USP 51

1030 - BIO Assay (in vivo), or on living cells or tissues (in vitro)

Co-ordination with, deviations handling and change controls, CAPA.

Audit coordination

Thoroughly trained for audit preparation and attended major audits viz., USFDA, TGA, MHRA and WHO