Vesna Koblar, M.D., Ph.D.
Vesna Koblar, the founder and principal of raPHARM, is an EU regulatory affairs consultant who helps pharmaceutical and device manufacturers develop market entry strategy, fulfill their regulatory and patient education mandates, and meet post-marketing surveillance requirements across the European Union and in CEE countries. She is also called upon by governments seeking to develop regulatory policy and legislation.
A physician and research scientist by training, she is a widely respected specialist in immune-hematology and transfusional medicine. In addition to a medical degree, she holds a Ph.D. in hemorheology.
After an early career as a practicing physician, Vesna spent over 15 years with the Slovenian Agency for Medicinal Products and Medical Devices, where she worked as Head of the Sector for Regulatory Affairs and then as a Deputy Director. She has also served as a national representative in the EU Council Working Group on Medicinal Products and Medical Devices, a member of the European Commission Standing Committee and Pharmaceutical Committee, and a number of other committees charged with oversight of both pharmaceuticals and medical devices. In addition, Vesna provided Regulatory Affairs expertise to the World Health Organization, the World Bank, EuroHealth Group, TAIEX, IPA and other agencies in over a dozen international projects.
In 2012, Vesna established raPHARM Consultancy, Education, and Training, a firm that offers regulatory consulting to manufacturers and MA holders; supports development of market strategy; guides dossier submission; develops customized courses and workshops in support of compliance; consults on market execution (including advertising review); and supports pharmacovigilance. Vesna also assists EU accession countries in aligning their legislation with the European Union Acquis Communautaire or EU Acquis.