Francis P. Crawley is the Executive Director of the Good Clinical Practice Alliance – Europe (GCPA) in Brussels, Belgium and a World Health Organization (WHO) Expert in ethics. He is the co-founder and a Steering Committee member of the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER). He is a philosopher specialised in ethical, legal, and regulatory issues concerning health research, teaching at several European, Asian, and Middle East universities. He is the past Secretary General, Ethics Officer, and Chairman of the Ethics Working Party at the European Forum for Good Clinical Practice. He has acted as an author or expert for the leading international and European ethics guidelines, as well as for several guidelines in Asia, Africa, the Americas, and Europe.
He is currently Chairman of the Ethical Review Committee of the International Network for Cancer Treatment and Research (INCTR), a member of the INCTR Tissues Committee, and a member of the Ethics Committee of the European Organization for Research & Treatment of Cancer (EORTC), and a member of the Steering Committee of the Chinese Ethics Committee of Registering Clinical Trials (ChECRCT). He is a consultant to the Beijing University Human Research Protection Program. He has been a member of the joint EMVI-AMVTN Ethical Review Committee, a Permanent Liaison Officer to the International Bioethics Committee of UNESCO, and a Contact Officer for the Council of International Organisations of Medical Sciences (CIOMS). For 2006 he was a Visiting Expert in research ethics in the Health Manpower Development Programme, Ministry of Health, Singapore.
He has been a member of the Scientific Advisory Committee for the World Health Organization’s International Clinical Trials Registry Platform (ICTRP). He also served for four years on the UNAIDS Ethical Review Committee. He is a co-founder and past Steering Committee Member of the Global Forum for Bioethics in Research, a past member of the Committee of Interested Parties of the Centre for the Management of Intellectual Property in Health Research & Development, a past member of the European Science Foundation’s Education Working Group, and a past member of the WHO GCP Handbook drafting committee. In addition, he is a member of the Working Group on Ethics, Union of European Medical Specialists – European Academy of Paediatrics (UEMS-EAP) [formerly CESP], and a partner in the following completed European Commission projects ‘The Development of European Standards on Confidentiality and Privacy in Healthcare among Vulnerable Patient Populations’, ‘Ethical Function in Hospital Ethics Committees’, & ‘Ethical Considerations in Clinical Trial Collaboration with Developing Countries’. He has led or participated in several European Commission paediatric research projects: (RESPECT, ENRAH, nEUroped, ENCCA, PAMPER.
He was the Co-facilitator for the Ethics Roundtable at the Africa Centre for Health & Population Studies in South Africa where he taught a modular GCP course and where he was a member of a DSMB for an HIV vertical transmission study. He is also a member of several regional organizations for ethics in research in Central and Eastern Europe, Asia, Africa, and Latin America. He was the Chairman of the Pandemic Advisory Committee to Roche (manufacturer of Tamiflu). He founded the AfroGuide Project: Developing Guidelines for Health Research in Africa, with the UN Economic Commission for Africa and the African Union. He also serves on several editorial boards for international journals, including Applied Clinical Trials, Pharmaceutical Medicine (formerly the International Journal of Pharmaceutical Medicine), Good Clinical Practice Journal, Journal for Clinical Studies, and the Journal of Empirical Research on Human Research Ethics. He is an Honorary Member of the Faculty of Pharmaceutical Medicine, Royal College of Physicians, United Kingdom.
Main area of interest: analysis of clinical research process; combination of medical science, statistics, programming and team management.
(2013 – present) Dr Balla is a Country Head, SrACOM (Senior Associate Clinical Operations Manager) at AbbVie, Site Management & Monitoring, Europe North-East, Hungary, R&D, Clinical Operations
Previously, (2008-2013) Clinical Project Leader at AstraZeneca Clinical Research Region – Central and Eastern Europe, Hungary, responsible for the management and organization of phase II-III (IV) clinical studies from A-Z: from preparation (draft protocol negotiation with opinion leaders, potential investigators, Regulatory Authority and Ethics Review Board experts, selection of sites), through clinical phase (initial training of site staff, monitoring) till ”clean file” (all procedures until declaration of ”clean file” incl. data cleaning, coding, consistency and error checking) local and regional study leadership.
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.
Dr. Martine Dehlinger-Kremer is Vice President, Global Medical and Regulatory Affairs at SynteractHCR, a CRO with headquarter in California. She has 30 years of experience in the clinical research industry, including more than 26 years of progressively higher levels of Regulatory and Medical Affairs leadership responsibility.
Dr. Dehlinger-Kremer is President of EUCROF, the European CRO Federation and a member of the board of EFGCP.
Dr. Dehlinger-Kremer has contributed to the global development of numerous products, including orphan drugs and biosimilars. She has participated in more than 100 New Drug Applications (NDAs) and Marketing Authorization Applications (MAAs) in local and common technical document format, eCTD and NeeS format; in the maintenance of products on the market and in numerous clinical studies across all phases.
Dr. Dehlinger-Kremer has served as Chair of the Paediatric Working Group of EUCROF (the European CRO Federation) since 2008 and has influenced the standards, protocols and number of trials conducted for drugs being administered to children. Dr. Dehlinger-Kremer is chair of the EFGCP (European Forum for GCP) Children Medicines Working Party. Dr. Dehlinger-Kremer is also Member of Working Parties of Enpr-EMA, the European Network of Paediatric Research at the European Medicines Agency.
Dr Dehlinger-Kremer was Named One of PharmaVOICE 100’s Most Inspiring People in Life Sciences (Industry leader recognized for impact, experience and advocacy in clinical research) in August 2015.
Dr. Dehlinger-Kremer holds a doctorate in sciences from the University of J.W. Goethe in Frankfurt, a general academic studies degree in neurophysiology from the Louis Pasteur University in Strasbourg, France, and a Master of Science from the University Moulin de la House in Reims, France.
Clinical research expert with over 16 years’ experience in the biopharma/CRO industry. Significant experience in operational and strategic management, leading teams of different sizes in different geographies (Hungary, CEE, MENA). Supervising and mentoring study teams in order to efficiently start-up local and global clinical studies, establish strong connection between various parties of clinical development.
I am relationship builder, a strong leader, a solution focused strategic thinker, experienced in building bridges and seeking continued improvements through innovations and change management.
Jaroslav completed the MSc. studies in biochemistry and PhD. studies in physical chemistry of the Natural Science Faculty of the Charles University in Prague. After his scientific career he started to work in the clinical research. He gained skills on several positions within CROs and pharma companies such as Quintiles and MSD. Further on he developed his managerial and leadership skills on positions such as Senior Project Leader at PAREXEL and Clinical Research Director in a biotech company Sotio.
He joined Penta Hospitals in the first half of 2016 as the Clinical Research Director to lead and further develop scientific and clinical research projects at Penta Hospitals International.
Jaroslav was born in Ustí nad Labem, northern Bohemia. He has got a son and a daughter. His hobbies are skiing and diving. He also acts as an international beach volleyball referee.
All-round Senior Manager with extensive experience in the Life Sciences, Clinical Research and Food industry. Currently as Programme Manager of European projects in the area of Clinical research setting up a clinical network of >750 hospitals across 40 European countries in the area of Infectious Diseases and setting up and organizing several large international clinical trials within the three European IMI projects for which University Medical Center in Utrecht is the Managing Entity.
Eight years CRO and Clinical Trial Operations experience as Senior Project Manager of International and National clinical trials and Managing Director of a medium sized international CRO.
A further >15 years Senior R&D and project management experience in the large multinational FMCG companies Unilever and Sara Lee/DE, now DE Masterblenders 1753, implementing the principles of 3rd Generation R&D, rolling out Food Safety QA directives and HACCP, training and coaching international product innovation teams. Additional QA, food safety and R&D experience in International Health & Food Nutrition as Director R&D with Royal Cosun (Suiker Unie & Sensus).
Expert experience in:
European Clinical Research projects and networks.
Project management of complex & large clinical trials
Business Development Clinical Research & Food Ingredients
Industrial Food Microbiology and QA expertise
Food Science & Nutrition expertise
Certified Project Management Trainer
New Product Development FMCG Food
PostDoc Molecular Immunology & Biologicals
PhD Molecular Biology
Barış Erdoğan is currently Head of EEMENA Region at Clinerion, responsible for business development and operations in Eastern Europe, Middle East and North Africa. He studied computer engineering at the Middle East Technical University in Turkey and holds M.Sc. and Ph.D. in educational technology. He lectures on the topics of software development, database management, medical informatics and project management. He has taken managerial roles in various ministry, banking and insurance secure applications. His expertise and interests 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.
Rosemary Bischoff has over 30 years’ experience as a medical writer, clinical project leader and line manager in the pharmaceutical industry. Her work covers the full range of Phase I trials and activities related to clinical trials and submission, and she writes review articles, original articles, conference proceedings, posters and training materials.
Rosemary’s major areas of expertise include Phase I, psychiatry, neurology, gynaecology, dermatology, oncology and endocrinology, and some experience in veterinary medicine research. She has approximately 14 years’ experience in training new staff, for example as line manager, workshop leader for the European Medical Writers Association and customised contract training.
For many years Rosemary was a member of the Educational Committee of the European Medical Writers Association (EMWA). During her time as a clinical project leader, she edited one book and self-authored scientific publications in both German and English, including six original articles, six review article and five posters.
Michaela Vancova, Clinical Operations Director, Co-Founder, Slovak research center
Michaela is chemical engineer with 11 years of experience in clinical research, from CRA, LCRA, PM in both CROs and big Pharma companies up to founding Slovak reeserch center, where she is the Clinical Operations Director. Previous companies: Icon, KCR, Octapharma, Boehringer Ingelheim.