Daniela Cristea Email & Phone Number

Provide support in the preparation of CCSI/CCDS for company productsReview of Aggregate Reports (PSUR, PBRER, PADER, AdCO)Coordinate/author of RMPs and overview of ARMMsSignal detection activitiesEvaluation of safety risks in Health Hazard Evaluation formsPreparation of responses to Health Authorities Requests

Preparevarious aggregate reports (PADER, PSUR, PBRER, DSUR)Conduct signal detection activities and preparation of Signal Assessment ReportPreparation of Health Hazard Assessment formsPrepare/update internal training documents

Preparation of Aggregate Safety Reports and RMPsPreparation of responses to Assessment ReportsProcessing and submission of ICSRs for company productsEvaluation of listedness/labelling of reported ADRs

• Compiling the quality documentation of registration dossiers in compliance with the legislation in force for authorisation/ renewal of medicinal products through national procedure (Module 1, Module 2 -Quality Overall Summary, Module 3)• Assist in responding deficiency letters

Bucharest, Romania

• Quality assurance of pharmaceutical products from current portfolio throughout the manufacturing process validation by: - Elaboration of the Validation Protocol and Validation Report - Manufacturing process of validation batches • Coordination of product transfer activities: -Perform the feasibility studies -Elaboration of preliminary documentation for the transfer process (Transfer Protocol, Variation record Card, Change Request) -Elaboration of Manufacturing Process for pilot batches an industrial scale batches -Coordination of raw materials and primary packaging materials purchasing activities (elaboration of List of Material Manufacturers (LMM) for the materials used for the first time in the production site in TrackWise system, elaboration of the purchasing requisition in SAP Athena program after checking of existing stock in SAP Athena program -Elaboration of the Bill of Material recipes for the manufacturing of industrial batches in SAP Athena program -Elaboration of Change controls and deviations in TrackWise system -Supervising of manufacturing processes for pilot and industrial batches, batches needed for the authorisation of the product transfers and for process validation▪ Partial elaboration of the necessary documentation for submission (part of Module 3)• Elaboration and periodical revision of the SoPs (Standard Operation Procedures) • Colaboration with different deparments :- Regulatory Affaires - for the elaboration of documentation for submission- Quality assurance - in order to authorise the documents elaborated (Manufacturing Process, Validation Protocol, Validation Report, Standard Operational Procedures)- Production- in order to plan and to manufacture the industrial batches for validation- Analytical development and Quality Control in order to evaluate the analytical test results obtained for the manufactured batches

Bucharest, Romania

• The development of new products for the company portfolio: Over the Counter, Prescriptions drugs, , Nutritional Supplements• Optimisation and reformulation of authorised products in order to improve the quality of the products and/or to increase the efficiency of technological processes• Development and implementation of pharmaceutical formulation strategies• Development of manufacturing processes for pilot batches, including the selection and the optimisation of the working parameters for scale-up from the pilot batch to industrial batch• Elaboration of the documentation for submission (part of Module 2- Quality Overall Summary and Module 3)• Selection of the supplier of Active Pharmaceutical Ingredient according with physicochemical characteristics and the pharmaceutical product developed• Selection of the excipients according with the physicochemical stability of the active substance and/or pharmaceutical form developed• Selection of the manufacturing method according with the API characteristics and the pharmaceutical form developed• Evaluation of the analytical test results obtained for the manufactured batches( in vitro dissolution test results, stability studies, quantitative analyses)• Performing of in process tests• Elaboration and periodical revision of the SoPs (Standard Operation Procedures)

Master’S Degree, Biostatistics

- Biostatistics - Statistical methods for demonstration of biodisponibility and bioequivalence of the pharmaceutical product - In vitro.

Bachelor Of Pharmacy (Bpharm), Pharmaceutical Sciences

Pharmaceutical Technology, Pharmaceutical Industry, Quality Control, Analytical Chemistry, Pharmacology, Pharmacodynamics.