Aleksandar Radojevic

Project manager in clinical trials.

-Development of Business plan for Clinical trial center formation in Serbia -Assessment of clinics for clinical trials -Development of documents for clinical studies-ICF, CRF, Source documentation etc. -Clinical Site Management - Phase II/III clinical trial of Influenza Vaccine; -Preparing documents for NRA and EC approval; -Preparing on-site documents -QA/ ICH GCP -Assistance to PI and investigator team -Team support during audit

-Development, optimization and validation of new steps in production -QA / cGMP -Preparation of pre-clinical and clinical testing of the vaccine -Preparation of documents for vaccine approval (National and EU) -Preparation of production, control and QA plans -Introduction and maintain of quality standards -Increase production capacity and modernize production -Reports preparation and presentation and evaluation of success

-Development of a plan for reconstruction of the manufacturing facility -Development of the manufacturing plan for whole, inactivated influenza vaccine -Preparation of project documents for WHO financial support -Preparation of tender documents and procurement of equipment -Production of API for Influenza vaccine

ICH GCP guidelines in clinical trialsNew trends and approaches in clinical trialsClinical trial documents preparation:-Protocol-Investigator Brochure-SOP-ICF-CRF

-Trends in vaccines control-GCP standards in clinical testing

-Project management tools-MS Project

GMP production environmentGMP recommendations in production designGMP recommendations in Quality control and Quality assurance​

Immunology, Allergology, Vaccines and ​Pharmaceutical production and control.

Advanced control on production processes (at influenza vaccine and yeast productions examples):-Continuous flow filtration-Ultracentrifugation-Tangential flow filtration​/ultrafiltration-Sterile filtrationIPC Control tests:-absorbance-residual tests-yield calculation-endotoxin-bioburden

Testing on biological products-SRID-Bioburden-Sterility-Endotoxin​

Influenza production process -production steps-yield calculation-GMP recommendations​Influenza control tests-SRD-Bioburden-Sterility testing-TCID 50-Endotoxin tests

General knowledge of human body, anatomy and physiology;General knowledge in mathematics, physics and statistics;Comprehensive knowledge in general and organic chemistry;Comprehensive knowledge in biochemistry, medicines and immunology;Comprehensive knowledge in biotechnology and bio-industry.