Audrius Sveikata

Biography

 Since 2001 I have co-founded CRO Biomapas performing all phases clinical trials in Baltics, Scandinavia, Poland, Ukraine, Georgia, Belarus and Russia. In the beginning we had focused mainly on bioequivalence studies with healthy volunteers, as a result we were involved in the development of the first biosimilar product (colony grow factor). Since then our clinical research activities have expanded into neighboring CEE countries and into all phases of clinical trials (I, II, III, post-marketing, safety surveillance, pharmacoepidemiology etc.). Currently we performing clinical monitoring and management, GCP training's for investigators, regulatory affairs (registration of medicines), clinical safety, and pharmacovigilace services. From 2014 member of the CRO alliance AICROS covering whole Europe and carrying-out complete clinical research service, access to the market and post-approval safety monitoring of the medicinal product. I have had extensive collaboration with European Regulatory Authorities, including State Medicines Control Agency of Lithuania (SMCA) and European Medicines Agency (EMA) during the last 10 years. I was clinical assessor responsible for scientific evaluation of safety and efficacy of product. Then appointed as a head of external assessor's team and was responsible for the administrative and procedural aspects of evaluation of the applications submitted in the country. Since 2011 a Member of the Board at Biomapas responsible for the scientific and clinical development strategy. In January 2013 I was appointed Managing Director of the company. Also I am a professor of pharmacology, I work part-time in Medical Academy, University of Health Science of Lithuania, I am involved in teaching and scientific work in neuro-psychopharmacology. Also active as a lecturer in various pharmacological, clinical research and life science conferences, author and co-author of more than 50 scientific publications.

Research Interest

 pharmacovigilance and clinical safety services