Anke Lehmann Starzetz
Regulatory Affairs Consultant @Eudrac
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WORK HISTORY
Regulatory Affairs Consultant @Eudrac
Pharmacovigilance services: ICSR processing/CIOMS, EudraVigilance/ICSR L2A reports, Literature monitoring/MLM, Signal Management, Gateway/EVWEB submissions, PV database systems (e.g. SafetyEasy PV/Extedo, BPI Pheda database system)- Quality Assurance: Document Management of procedural documents- Regulatory tasks: Support EU Marketing Authorisation Procedures (CP, MRP/DCP, NP) and medicinal product lifecycle management (variations, EURD Listing review for PSUR), competitor surveillance, support of review product information, educational materials, promotional materials
EDUCATION
projektpartner management gmbH
Certified Project Management Associate IPMA Level D
Berufliches Schulzentrum f. Gesundheit u. Sozialwesen d. Stadt Leipzig (Dr. Ruth-Pfau-Schulzentrum)
staatlich geprüfte medizinische Dokumentationsassistentin, Medical Document Manager
Medizinische Berufsfachschule am Universitätsklinikum Leipzig
no degree, Medizinisch-techn. Laboratoriumsassistenz (MTLA) / Medical Lab Technician
ABOUT ANKE LEHMANN STARZETZ
Regulatory Intelligence + PV Intelligence intelligence in pharmacovigilance provides the basis for proactive risk management and informed decision-making. It translates evolving regulatory requirements into strategic actions and strengthens compliance throughout the entire lifecycle of a medicinal product. In this way, patient safety is not only ensured, but continuously advanced.Core process of Regulatory Intelligence:Capture and triage - Analysis and impact assessment - Specification of requirements - Implementation in processes and systems - Monitoring and continuous improvementField of activities- Drug Safety/Pharmacovigilance of medicinal products for human use/veterinary use - clinical trials and postmarketing- literature monitoring, competitor surveillance- EudraVigilance (EVWEB, MLM, L2A-reports)- Safety database systems (e.g. SafetyEasy PV/Extedo, BPI Pheda)- Support aggregate reports (DSUR, PSUR), signal managementQuality Management/Assurance- Compliance, procedural documents (Policies/SOPs/WIs)- Vendor management- Change Control- Root-Cause-Analysis and CAPAsTherapeutic focus:Oncology/Hematology, Infectious diseases, metabolic diseases, cardiovascular diseases, gastroenterologyAdditional interests- Artificial Intelligence in Pharmacovigilance/Drug Safety and Regulatory Affairs- Artificial Intelligence meets Reg Intelligence
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