Ewa Schran

• Medical assessment of Individual Case Safety Reports, generating of periodic safety reports, submission of ICSRs to EMA • Screening and assessment of scientific literature, performing activities related to signal identification and management • Responsibility for continuous Quality Management System improvement and its global harmonization. Creation and maintenance of PV processes as well as the update of associated SOPs and other controlled documents • Support of inspection readiness and training of PV

Ensuring clinical and general quality processes are conducted in accordance with national and international laws, regulations and guidelines regarding GCP. Serving as an advisor for QA affairs for other departments •Performance of audits in the frame of clinical studies • Internal and external system audits•Review and approval of essential clinical study documents • Support of inspection readiness and inspection management • Enhancement of internal standards (SOPs) and ensure compliance with ICH-GCP standar

Project lead for the development of hair products• Global regulatory, product safety and quality related compliance assessments for cosmetics and borderline products and their raw materials• Functional leadership in multi-disciplinary project teams enabling product innovation via development and implementation of global compliance strategies • Monitoring of emerging legislation and coordination of regulatory change management• Review of safety and quality standards for new product concepts

Pharmaceutical Specialisation