Team of experts

After an early career as a physician, Ms. Koblar 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, Pharmaceutical Committee and Competent Authorities Medical Devices Committee, and a number of other committees charged with oversight of both pharmaceuticals and medical devices. Ms Koblar has provided Regulatory Affairs expertise for over twenty international projects and worked with WHO, World Bank, EAR, EHG, ADETEF, BSI, TAIEX… on IPA, ISPA and EuropeAid projects. She also assists EU candidate countries in aligning their legislation with the European Union Acquis Communautaire or EU Acquis. Close

He was also a member of the Pharmaceutical Committee and he was one of the founders of EMACOLEX, the group of lawyers of the competent authorities in the EU. From 1999 until 2007 Mr Lisman was policy adviser in the Medicines Evaluation Board. He was active in the Pan European Regulatory Forum, an initiative to prepare acceding member states in the organisation of legislation and authorities. He was also a member of the EMA management board and the Heads of Medicines Agencies. In 2007 Mr Lisman started as lawyer trainee at NautaDutilh and was admitted to the bar. Since 2010 he runs the law firm Lisman Legal Life sciences. Close

He has a long term experience in the complete managing and organizing of clinical studies phases I-IV (placement of studies, handling of the local regulatory/legislative issues, support in obtaining a marketing authorization), monitoring and auditing clinical studies and particularly giving training courses in ICH-GCP, and GLP. Besides the experience in GCP area, Mr Gielsdorf has extensive international project managament and consulting experience in the chemical/pharmaceutical industry (R&D, Marketing, Business development). He participated in projects sponsored by the European Commission, UNCTAD/WTO, World Bank… as consultant/expert in the healthcare for governmental bodies/public institutions and the industry, mainly in several Central and Eastern Europe (public health, national drug policy, regulatory/legislative issues, and effective administration), Near East and some of CIS Countries. He assisted also in preparing and implementation of GxP-compliant Quality Management Systems (QMS) following ISO 9001 and 17025. Close

Mr Holy worked a number of years as Head of Inspection in the Institute for State Control of Veterinary Biologicals and Medicines, Czech Republic with long standing and active involvement in international forum: Representative of the Institute at the Head of EU Medicines Agencies working group of enforcement officers (WGEO vet), at PIC/S Committee of Officials, body responsible for decision taking within PIC/S, and at the EMA working group of inspectors (GMDP IWG). He was also elected member of the Executive Bureau of PIC/S, managing board of PIC/S. Mr Holy is actually USP External GMP consultant and PIC/S expert of the United States Pharmacopeial Convention. He is involved in many international projects connected with the improvement of GMP compliance through training of local inspectors in GMP and inspection methodology. Mr Holy was speaker, moderator, and facilitator for many training courses, workshops and conferences. Close

As a member of the Permanent Representation of the Republic of Slovenia to the European Union Ms. Soljačič prepared and presented Slovenian positions at the Working Groups of the Council dealing with proposed new EU legislation concerning horizontal issues for functioning of the Internal Market, legislation concerning goods, services and legislation on protection of the consumers. She was actively involved in preparation for Slovenian Presidency of the Council of EU and was a chair-person of the Council Working groups: Competitiveness and growth, Technical harmonization and Consumer protection. Ms. Soljačič participated in final negotiations for adoption of New Legislative Framework related to »quality infrastructure«, mutual recognition in non-harmonized areas and general approach and consistency of the future EU legislation concerning free movement of goods what was adopted at the EU level in 2008. Close

His research interests include development of in vitro and in vivo tests in biopharmaceutics and pharmacokinetics, development of experimental models for studying interactions, transport and metabolism of drugs in biological systems of increasing complexity, pharmacokinetic-pharmacodynamic analysis using compartmental and hybrid models, statistic and computer aided design of drug delivery systems, development of site-specific microspheres for intravesical and colonic delivery, pharmacoepidemiologic and pharmacoeconomic analysis, and finaly outcomes research (clinical, economic and humanistic outcomes in relation to drug medical treatments). Mr Mrhar is an author and co-author of more than 180 articles published in international peer-reviewed journals. He is recipient of the national award for the achievements in research on the field of mathematical modeling and computer simulation in pharmacokinetics, in 1990. Moreover, he is founding father of Central European Symposium for Pharmaceutical Technology which is organized biennially since 1995, and in this capacity acts as guest editor of thematic issues of International Journal of Pharmaceutics and European Journal of Pharmaceutical Sciences. He has a long term experience in assessing documentation of Quality of medicines and BA/BE studies as a member of team of expert in Slovenian national Competent Authority for medicines. Close