Bora is the founder and director of EuroPharm since 2009. As an experienced pharmaceutical professional, he has worked on multiple aspects of the clinical development cycle, including clinical research, pharmacovigilance, medical information, vendor management, and clinical quality assurance.
Bora has extensive clinical experience as a physician, both as the operational and medical expert in numerous clinical research programs. He has conducted more than 200 compliance audits spanning all aspects of pharmacovigilance and risk management, including corrective action planning, documentation reviews, Good Clinical Practice and business due diligence in support of Marketing Authorization activities. He has a strong appreciation for the value of diversity coupled with an ability to work with others to accomplish both team specific and individual goals.
Currently, as an independent consultant, he continues to conduct mainly pharmacovigilance and investigator site audits as well as advises CROs, biotech and pharmaceutical companies on how to maintain compliance and implement industry best quality practices in the complex regulatory environment of pharmacovigilance.
Bora SEVER, MD
Melis joined the company in 2017 as a freelance Clinical Research, PV, Quality Assurance Associate. She has wide experience in the management of trial projects with leading CROs and international pharmaceutical companies as well as PV audit management including CAPA processes.
She has a strong grasp of international standards and ethics in the sector with diligent documentation supporting drug safety in addition to clinical trials. She is now responsible for managing Europharm projects for the delivery of QA GxP services to clients, ensuring of compliance of processes with the applicable GCP/GVP legislation, Client’s requirements and quality standards.