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CEE Countries Prepare for New Clinical Trial Regulation
Published Date: Jan 01, 2020Critical for these Member States to define clinical trials designed to provide patient access to innovative treatments under new CTR
Author(s)
Ms. Mihaela David
Director Regulatory Affairs
PSI Pharma Support Romania
Mihaela David, Director RA department at PSI CRO AG, based in Bucharest. Senior Pharmacist by education, with 15+ years of experience in the pharmaceutical and clinical trials industry, responsible for coordinating regulatory submissions and related processes in multiple European countries. My main focus of activities is related to the implementation of the Clinical Trial Regulation in PSI and to the compliance with the pharmaceutical and quality related European guidelines. I am a member of DIA since 2014, the organization that offered me the opportunity to be part of the exclusive group of experts in clinical trials in Europe.