The leading event for all parties involved in the clinical trials market in CEE

17 - 18 April 2018

Education: Medical Doctor Postgraduate Degree in Paediatric medicine

Employment:

2 years as pathologist
3 years as Paediatrician in hospital
1 year as Paediatricien Oncologist
2 years in pharmaceutical company
since 2003 as clinical assessor in department for clinical trial at the Institute for Drug Control ( NCA-national competent authority))
since November as a chief of clinical trial department
since 2008 member of CTFG ( Clinical Trial Facilitation Group) established by HMA in 2004 and Ad hoc (Europ. Com.)

Dr. med. Ingrid Klingmann, FFPM, FBCPM studied medicine in Germany and specialized in General Medicine, Clinical Pharmacology and Pharmaceutical Medicine.

 

Physician, specialized in General Medicine, Clinical Pharmacology and Pharmaceutical Medicine with over 30 years of experience in different senior medical, operational and managerial functions in pharmaceutical industry, CROs and clinical trial sites with focus on clinical trial design and management, ethical and regulatory aspects.

Since January 2003 she has her own pharmaceutical development and site management support consulting company.

Dr. Klingmann is Chairman of the Board of the European Forum for Good Clinical Practice (EFGCP). On behalf of EFGCP she was and is involved in different FP7- and IMI-funded projects (ICREL, PatientPartner, PharmaTrain, EUPATI, Combacte-Magnet) and with her company in the FP7-funded paediatric LENA project and the IMI-project SPRINTT. Her broad professional background as physician with experience in patient care, clinical development, site management and patient engagement enables Dr. Klingmann to bridge the gaps between the interests and skills of all different stakeholders in medicines development with the aim to develop new patient-relevant treatments more efficiently.

Dr. Klingmann is also President of PharmaTrain Federation and teaches different topics in diploma and master courses at the University of Bonn, Germany, University of Basel, Switzerland, and the Université Libre de Bruxelles, Belgium.

Mr Piotr Drobek graduated from the University of Warsaw, Faculty of Law and Administration in 2000. Then he worked in several departments of the Bureau of the Inspector General for Personal Data Protection. At present, he is a Deputy Director of the Social Education and International Co-operation Department. He is a Chair of the Joint Supervisory Authority Customs and a Chair of the Customs Information System Supervision Coordination Group. He is also a lecturer at the Faculty of Law and Administration of the Cardinal Stefan Wyszynski University in Warsaw.

Dr Szczukiewicz is a clinical research professional with broad CRO and pharmaceutical experience concerning all phases of clinical trials. Currently responsible for management of Central & Eastern European region in regards to projects set up, execution, oversight and reporting, providing local strategic planning and organisation to achieve successful studies completion. Since 2016 Dr Szczukiewicz has been a Member of the Board and Chairman of the Training Group at Association for Good Clinical Practice in Poland (the biggest professional non-profit organization in Poland).

Gjon Mirdita graduated from Dentistry School in Zagreb, Croatia in 1998. After an internship he joined Quintiles as a Clinical Research Associate and within a few years became a Clinical study manager. In 2007 he was tasked to establish the Site Start - Up department within Quintiles for Eastern Europe and Middle East out of the Regional Headquarters in Vienna and three years later in 2010 he became head of Global Regulatory and Start-Up. In 2013, he stepped out from Quintiles to join the creation of AbbVie in the Adria region taking on the role of the Medical Director. In 2016, he returned to Quintiles as a Vice President for Site management in Central Eastern Europe, Middle East and North Africa.

Tamás Bereczky currently works as the communications advisor of the European AIDS Treatment Group (www.eatg.org), the largest European network of individuals living with HIV, and as the communications officer and trainer of the European Patients’ Academy for Therapeutic Innovation EUPATI. HIV positive since 2003, he served as a member of the board of directors of the EATG for almost 4 years, and also served the co-chair of the European Commission’s Civil Society Forum on HIV/AIDS between 2013 and 2015.

Graduated from Semmelweis University as a Medical Doctor in 1993; researcher and physician at the National Institute of Cardiology, Budapest for 6 years and received here his internal medicine board certification; fellowship worker at University of Parma in 1996; founder and manager of the Goodwill Research Ltd., a company with main focus on pharmaceutical and clinical research, from 1998 for more than 10 years; co-founder and later executive director of the reorganized Svábhegy Pediatric Hospital, co-founder and director of Auxiliis Clinical Development Ltd, co-founder of Medicines for Children Research Network Hungary.

PhD Biophysical Pharmacology, MSc. Physics
>30 years in biopharmaceutical research and development
Research cardiovascular pharmacology, and oncology
Slovak Academy of Sciences, Bratislava, Slovakia
The George Washington University Medical School, Washington DC, USA
National Cancer Institute at NIH, Bethesda, MD, USA
Product development/CRO Quintiles
VP & Head of global centralized operations center (GDN), India
VP & Regional head of CEE and MENA clinical operations
Head of Business development CEE and MENA
Currently:
SanaClis sro, Board Member, www.sanaclis.eu
Full-service European CRO
LongTaal sro, Founder & Partner www.longtaal.com
Advanced clinical trial informatics and advisory services
> 60 research articles and book chapters in peer-reviewed journals, currently focusing on various aspects of globalization of industry clinical trials:
co-author of Clinical Trials in the Middle East and North Africa (in Global Clinical Trials, Elsevier 2011, eds. R Chin, M. Bairu))
V Misik, Shifting Sands: Global Clinical Trials: MENA Region, European Pharmaceutical Contractor, September 2011, pp 66-70
V Misik, Expected Growth of Industry-Sponsored Clinical Trials in the Middle East Benchmarked on other Global Regions, Quintiles White Paper, February 2012, pp 1-12
V Misik, Room to Bloom in MENA, Emerging Markets: MENA, SCRIP, April 2012, pp 20-22
V Misik,, RV Brady, M Bolecek and H Klech, Current Trends in Globalization of Industry-Sponsored Clinical Trials, Applied Clinical Research, Clinical Trials & Regulatory Affairs, 2014, 1, 56-66
Mišík V., Boleček M., Brady R.V. (2017) Ethical Considerations of Industry-Sponsored Clinical Trials in the Arab Region. In: Silverman H. (eds) Research Ethics in the Arab Region. Research Ethics Forum, vol 5. Springer, Cham, pp. 161-170
Misik V, Brady RV, Boleček M, Klech H: Recent trends in globalization of industry R&D clinical trials: are emerging markets losing their allure? Applied Clinical Research Clinical Trials and Regulatory Affairs, June 2017. Vol 4, pp. 175 - 182

Konstantin Kachulev, MScPharm

graduated as a pharmacist in 2006 at Medical University Sofia in the Faculty of Pharmacy. Additionally he obtained a specialization in Industrial pharmacy. Now, he is a PhD student in social medicine and healthcare and pharmacy management at the Faculty of Public health ,and additionally studies specialisation in Toxicology and toxicological analysis at Faculty of Pharmacy.

A former member of the Executive Committee and the Regulatory Commission оf Bulgarian pharmaceutical union (BPhU), current member of the American Chemical Society, Bulgarian Association for Drug Information and a Pharmacovigilance and drug safety project manager at a CRO. Expert in the national working groups of National Drug Policy, Pharmacy Roadmap for Bulgaria and in E-health. He has management and business development experience in pharmaceutical production, in pharmaceuticals and food supplements trading, in community pharmacies and in the CRO development.

Currently he is a President of Regional Pharmaceutical Association at BPhU in Blagoevgrad-region and a President of a NGO ‘Experts for Prosperity of Civil Society’. His interests are in the fields of drug safety, pharmacovigilance, medical device vigilance, cosmetovigilance, clinical research, and healthcare and pharmaceutical politics. He has experience in the therapeutic areas of Immune mediated inflammatory diseases, Infectious diseases, Cardio metabolic diseases, Neurology and Oncology. More than 10 years’ experience in different fields of the pharmacy in Bulgaria. He is also experience as a head of a professional group for implementing pharmacy job positions into the national labor legislation. New positions have been adopted via Minister order. A joint action person between the professional group for Pharmacy Accountable Software companies and the new founded Bulgarian association for medicines verification.

  • Medical Doctor specialized in Family Medicine 
  • Clinical Research Manager, Bionure
  • Senior Consultant, DEP Institut
  • Medical Director,  Laboratorios Rubió
  • Medical Director,  Hartington Pharmaceutical
  • Medical Director, Laboratorios SALVAT S.A.
  • Medical Director, ConvaTec Spain (Bristol Myers-Squibb)
  • Medical Affairs Manager, Laboratorios Almirall
  • General Practitioner in Primary Care, Barcelona Generalitat of Catalonia.

Jenny Preston – Patient and Public Involvement and Engagement (PPIE) Priority Lead, National Institute for Health Research (NIHR) Clinical Research Network (CRN) and Patient and Public Involvement Manager for the NIHR Alder Hey Clinical Research Network (CRF)

Jenny joined the NIHR Clinical Research Network (hosted by the University of Liverpool) in 2005 as a full-time Consumer Liaison Officer for the Medicines for Children Research Network (MCRN).  For 12 years Jenny’s main role was to develop and implement a strategy for involving children, young people, parents and carers in all aspects of the ensure the inclusion of a lay perspective in the design and delivery of paediatric research.  Jenny set up and currently supports a National Young Persons’ Advisory Group called GenerationR (www.generationr.org.uk), which has enabled over 100 young people to have a voice in research design and delivery.  Jenny now leads on National projects, such as the National Institute for Health Research (NIHR) Patient Research Ambassador Initiative (PRAI) http://www.nihr.ac.uk/patient-research-ambassadors which supports patients and researchers to actively promote research in NHS Organisations in England. 

Jenny also coordinates and manages the active involvement of children, young people and families in the deliverability of research in the UK, across Europe via the European Young Person’s Advisory Group Network (eYPAGnet) and via the International Children’s Advisory Network (iCAN) which she helped set up.

Dr. Oleksii Mikheiev is currently the Chief Operating Officer at Verum CRO (Germany) and, Regional Managing Director at Cluster Verum Office in CIS Countries. Since 2016, he heads Clinical Trial Subcommittee of European Business Association.

He joined clinical trial business in 1998 after three years of experience as sub-investigator in phase II-III clinical trials. Totally he has 21 years of experience in clinical trials conduction and, particularly, 17 years of experience in CRO general management. He manages the CRO with strong and sufficient experience of phase II-III clinical trials in oncology. He was a member of several working groups of Ministry of Health for drafting the clinical trials legislation in Ukraine. He has experience of collaboration with international organizations (WHO, UNAIDS and UNICEF) as the temporary advisor. Oleksii Mikheiev holds M.D. degree from the National Medical University in Kiev, Ukraine since 1994, received Ph.D. degree in medicine in 2000 and became associated professor in 2014.

Dr Borogan has a medical background and since 2006 has gained expertise of working in both CROs and Pharma. He began as a CRA at Quintiles specialising in several therapeutic areas. In 2012 he began managing clinical operations for Eli Lily after which he became a start-up specialists for multiple countries. Since August 2016 he joined Synesux to focus his expertise on managing the Romanian clinical trials market.

Barış Erdoğan is the Head of EEMEA Region and country manager of Clinerion Turkey. He studied computer engineering at the Middle East Technical University and holds M.Sc. and Ph.D. in educational technology. His expertise and experience include management of innovative Medical Informatics projects and implementation of end-to-end Healthcare IT enterprise information systems, both in the public and private sectors.

Consultant psychiatrist in child and adolescent mental health (CAMH); Head of the Department of Child and Adolescent Psychiatry in The Institute of Psychiatry and Neurology in Warsaw since 2010; graduated from The Poznan Medical School in 1997. Four years later has received Ph.D title and in 2008 has successfully completed habilitation dissertation on traits of temperament and genetic factors in anorexia nervosa. Since 2008 has well-established position as a main Editor in the editorial board of "Wiadomości Psychiatryczne". He has published numerous papers in peer-reviewed journals on the etiology and pharmacotherapy of mental disorders. He has translated into Polish many fiction and popular science books, including: "The Demon-Haunted World", "American mania: When More is Not Enough" and "The Unquiet Mind".

Mr. Eytan Oppenheim serves in the capacity of International Business Development at Synektik S.A. One of the high-lights of his activity in this area is the long-term know-how transfer in the area of PET tracers from Hadassah Medical Center in Israel to Synektik coupled with a grant awarded by the EU, the highly competitive Horizon 2020 program. Currently Eytan is engaged in launching a new service for supporting clinical trials with cyclotron produced PET tracers in Central Europe.
Eytan also serves as a director at Hadasit Ltd. the technology transfer company of Hadassah Medical Center in Israel, a company engaged in technology transfer from the research conducted at the hospital toward commercialization.
In Israel Eytan served as Managing Director of Ankersmid Ltd. (formally Galai Ltd.), a wholly owned subsidiary of the Dutch based scientific equipment company, leading investors from the Netherlands to Israel and launching the R&D and international marketing activities.
The close ties of Eytan with the Central European medical imaging market go back to the 90’s when he relocated to Vienna to set-up the Central European Headquarters of Elscint, a multinational Israeli based pioneer company engaged in medical imaging equipment. Through a series of takeovers and organic growth actions the headquarters in Vienna grew within 5 years to manage a number of wholly owned subsidiaries coupled with distribution channels in neighboring territories. Prior to that Eytan relocated to Australia to head the local sales and service subsidiary of Elscint there.
Eytan holds a B.A. in economics from the Hebrew University of Jerusalem, Israel and a M.Sc. in Industrial Management from the Technion - Israel Institute of Technology.
Eytan is married and has 2 children. Beyond enjoying reading books, listening to music and world travel, Eytan finds satisfaction in teaching entrepreneurship courses at Haifa University, Israel, to graduate economics students.

Michaela is chemical engineer with 12 years of experience in clinical research, from CRA, LCRA, PM in both CROs and big Pharma companies up to finding Slovak research center, where she is the Clinical Operations Director. Previous companies: Icon, KCR, Octapharma, Boehringer Ingelheim. Slovak research center is a member of Society of Clinical Research Sites, where Michaela is active in more Site Advocacy Groups.

Dr. Vesna Popovska has successfully developed and established the Neurosciences Research Program at BC Children’s Hospital. She leads the entire research program including the Division of Pediatric Neurosurgery and Division of Pediatric Neurology. She has pioneered the concept of a research manager running different research programs in the Children’s & Women’s Health Centre of BC, which now serves as a model for building similar research programs at BCCH and other hospitals in BC and Canada.

Janusz Kabata MD, PhD, MBA is a successful entrepreneurial healthcare professional with over 35 years of academic and executive experience in public and private healthcare sectors in Europe, and 25 years experience in various aspects of clinical trial management, including managing central laboratory services as well as home-care services for European and global clinical trials.

He is co-founder of MedConsult that develops European GP Practice-Based Research Network – gp4research. Prior to MedConsult, he co-founded GlobalCare Clinical Trials Ltd, and developed the network of home care service providers in Europe and Asia. He established Synevo Central Lab.  He is specialist in public health and laboratory medicine.