Μουζοπούλου Βαρβάρα

Barbara Mouzopoulou has extensive experience in the pharmaceutical industry, with a focus on regulatory affairs.

She has excellent knowledge of regulatory requirements and legislation within EU, USA, Australia, Canada and many other countries in the field of essentially similar products. She has a strong knowledge of GMP and GCP/GLP requirements, an R&D analytical background and excellent CMC knowledge and experience.

Familiarity with clinical and non-clinical requirements in the field of generics for solid dosage forms, ophthalmic forms, parenteral forms.
 
Barbara is currently serving as the Director of Regulatory Affairs at DEMO Pharmaceuticals S.A. since March 2023.
 
Prior to this, Barbara held similar positions as Regulatory Strategy Director and Regulatory Affairs Director at RAFARM S.A from March 2018 to February 2023. Barbara was responsible for all registration activities, covering territories such as the EU, USA, Canada, and Australia. 

Barbara also played a key role in pharmacovigilance and clinical affairs projects.
 
Before joining RAFARM S.A, Barbara held various positions at Genepharm SA. starting from June 2004. From October 2012 to February 2018, she served as the Director of Regulatory Affairs and EEA QPPV. In these roles, Barbara was responsible for regulatory activities within the EU and other non-EU territories like Turkey, Australia, and Canada. Barbara was supervising the compilation of quality documentation for submissions and collaborated with third parties on patent issues, bioequivalence studies, and regulatory strategy. 
 
Before joining the regulatory affairs sector, Barbara's also worked for short periods of time as medical representative at Boehringer Ingelheim from January 2001 to June 2001. Barbara then worked, as a Chemistry Professor at Hellenic Airforce Academy from October 2002 to June 2003. She also gained experience as a Senior R&D Analyst at Kleva S.A. from March 2003 to May 2004 and as a Laboratory Tutor at Technological Institute of Athens from October 2001 to June 2004.
 
Barbara Mouzopoulou obtained her PhD in Chemistry from National and Kapodistriakon University of Athens, where she studied from 1996 to 2001. Prior to her doctoral studies, she completed her undergraduate degree in Chemistry at the same institution from 1990 to 1995. Barbara's educational journey began at 1st High School Holargos, where she attended from 1985 to 1988.