Agnieszka Kurowska-Fasuga

Main responsibilities:
•Literature (non-indexed and indexed) screening and reviewing in order to identify ICSRs and safety-related findings as well as efficacy data
•Obtaining copies of the full English literature articles
•Individual Case Safety Report processing using ARISg database
•Regulatory reporting (hard copy, electronic via EudraVigilance)
•PSUR/ASR preparation, production of: line listening, summary tabulations, Individual Case Safety Report (ICSR) summaries

Main responsibilities:
•Working on post-approval variations according to national procedures (on Polish and foreign markets) by
preparing appropriate documents (variation package)
•Verifying process validation reports in order to direct to the appropriate Registration Agency
•Corresponding with the Local Regulatory Affairs in order to keep the most up-dated registration drug status

Main responsibilities:
•Preparing application forms with the appropriate attachments for the new drug products and raw
pharmaceutical materials
•Taking control of the registration status of drug products on the Polish market by preparing re-registration
documents and post-approvals variation packages according to pharmaceutical law
•Corresponding with the Registration Agency in Poland concerning the registration processes that I was responsible for
•Looking for new suppliers and corresponding with already registered producers and suppliers to order and receive samples designed for analysis. Certificates of analysis were needed for the registration purpose
•Preparing validation reports of analytical methods for the drug products and raw pharmaceutical materials in order to send data to the Registration Agency
•Performing chemical analysis of drug products and raw pharmaceutical materials for registration purposes
•Performing physical and chemical analysis of package materials designed for drug products and raw
pharmaceutical materials
•Working on preparing new drug forms according to European Pharmacopoeia
•Preparation of stability reports for drugs and raw pharmaceutical materials using data from chemical
analysis I achieved by testing samples according to drug product’s specifications
•Preparation of registration documents for raw pharmaceutical material in such a positive way, ensuring that the Registration Agency gave us the permission for that product without any deficiency letter

Main responsibilities:
•Performing chemical water and sewage analysis in the laboratory
•Performing physical and chemical leather analysis before I prepared appropriate samples