Dear colleagues and friends,
I am very pleased to announce you that we have reached this year at the 8th edition of our symposium organized in Bucharest, Romania.
We invite you all to join us for our event dedicated to professionals working in clinical research field, pharma sponsors, biotech companies and CRO’s representatives, investigators (clinicians and general practitioners, laboratory specialists (lab physicians, chemists, biologists, biochemists, etc.).
You will have the chance to listen presentations of very well known speakers, KOL in their field, into a relaxing environment where you can also build and cultivate relationships and do the networking with your peers.
The event is credited with CME credits.
Be the first to register on our website where you will find all necessary details of this professional meeting of Clinical Trials specialists. Please be aware that there is a limited number of participants.
Years of tradition
István graduated at KLTE, in Debrecen, Hungary as a mathematician in 1990.
He has been working as biostatistician since then. He spent four years at Semmelweis Medical University (Budapest) supporting the academic research conducted by the university teams and individuals.
After the Berlin wall fell a very sparkling life started in Hungary with marketing hundreds of new drugs to a market which required new study results including Hungarian patients. After a short freelancer period István started Planimeter Kft, a full service CRO which still has been managed by him. He designed, evaluated and reported numerous studies covering pre-clinical, Phase I-IV studies and post-marketing surveys during 25 years of his activity. Beyond acting as statistician István also collected rich experiences in Data Management. With his team he implemented an electronic CRF system which currently operates in 8 countries and designed several Patient Registries.
He also works as contract statistician time-by-time. He started with Accovion in 2009 and continued with CSL Behring in 2011, Bayer Healthcare (2013) and Novartis (2015). István has been a member of ISCB (International Society for Clinical Biostasticians) since 1990 and DIA (Drug Information Association) from 2013. Author or co-author of several publications, including a book on Statistics (in Hungarian).
Clinical Institute of Laboratory Diagnostics, Clinical Hospital Center Zagreb, Croatia
Prof. Dunja Rogić, PhD, medical biochemistry specialist, graduated in 1986 from School of Pharmacy and Biochemistry, University of Zagreb, in the 1986-1987 period she did postgraduate study at School of Pharmacy and Biochemistry, University of Zagreb, she was in the 1987-1992 employed in Laboratory for Endocrinology, University Hospital Center Zagreb, in 1991 defended her master's thesis, in the 1992-1995 period was a resident in laboratory medicine (in 1995 she passed specialist exam in laboratory medicine), was Head of General Clinical Chemistry Laboratory, University Hospital Center Zagreb in the 1995-2002 period, won her PhD degree, and was awarded MBA degree - Leadership and Management in Health Services, Zagreb University School of Medicine and London School of Economics (2001-2003). In 2008 she was elected Assistant Professor at School of Pharmacy and Biochemistry, University of Zagreb, and since 2013 she has been Head of Department of Laboratory Diagnostics, University Hospital Center Zagreb, and Associate Professor at School of Pharmacy and Biochemistry, University of Zagreb.
She has been an invited speaker/participant in many scientific meetings in Croatia and abroad, author and co-author of more than 50 scientific papers. Her fields of interest: evidence-based medicine, POCT, organization & management of clinical laboratory, laboratory parameters of renal diseases. She has been a lecturer and organizer of continuous education courses for physicians and medical biochemists, and editor/co-editor of several textbooks and author of book chapters. She is a full member of EFLM Postanalytical WG. She is actively involved in undergraduate and graduate teaching at School of Pharmacy and Biochemistry, University of Zagreb, and School of Medicine, University of Zagreb; course leader: Evidence-based Laboratory Medicine.
Professor of Clinical Chemistry at the Medical Faculty, George-August-University Göttingen, Germany
Michael Oellerich, MD, Hon MD, FACB, FAMM, FFPath (RCPI), FRCPath, is a chemical pathologist. Since 2012, he has an appointment as a Lower Saxony Distinguished Professor of Clinical Chemistry at the Department of Clinical Pharmacology, Medical Faculty (UMG) of the George-August-University Göttingen, Germany. He was chairman of the Department of Clincal Chemistry/Central Laboratory at UMG from 1991 to 2012. He received the Fellowship of the Royal College of Pathologists (FRCPath) in 2006, as well as the Fellowship of the National Academy of Clinical Biochemistry (FACB) of the American Association for Clinical Chemistry in 2012. Since 2013, he is a member of the Medical Advisory Board of Chronix Biomedical Inc., San Jose, CA, USA. From 1996 to 1998, he served as Dean of the Faculty of Medicine and as the deputy of the chief executive for research and teaching on the executive board for the Medical Center and Faculty of Medicine from 1999 to 2004. He was president of the International Association of Therapeutic Drug Monitoring and Clinical Toxicology (IATDMCT) from 1997 to 1999, president of the German Association for Laboratory Medicine from 2001 to 2002, president of the German United Association for Clinical Chemistry and Laboratory Medicine (2003-2005), secretary-treasurer of the World Association of Societies of Pathology and Laboratory Medicine (WASPaLM) from 2005 to 2007, president of WASPaLM from 2009 to 2011, and immediate past-president of WASPaLM from 2011 to 2013. Since 2016, he is secretary of the International Society of Enzymology. Currently he is the Director Europe of WASPaLM and chair of the board of the Labs Are Vital consortium. From 1999 to 2010, he was a member of the Steering Committee of EUROLIFE, a network of European centers of excellence in life sciences. Since 2003, he is Editor-in-Chief of the journal Therapeutic Drug Monitoring. He was Associate Editor of Clinical Biochemistry (1996–2007), Associate Editor of Clinical Chemistry (2007-2013), and Guest Editor of Clinica Chimica Acta (special issue) in 2012. He was on the Editorial Board of Clinical Chemistry (2002-2007; 2014-2016), and currently is on the Editorial Boards of Clinical Biochemistry (2015-) as well as of J Mol Clin Pathol, Folia Med, Turk J Pediatr Biochem, and Indian J Clin Biochem. He is member of the Advisory Boards of Ital J Lab Med and Braz J Pathol Lab Med. His current research interests are in the field of therapeutic drug monitoring, with particular focus on endogenous biomarkers to achieve personalised immunosuppression in transplantation (e.g.graft-derived circulating cell-free DNA as “liquid biopsy”), as well as genotype-directed cancer care using cfDNA. Further topics include proteomics, and analytical techniques (e.g. LC-MS/MS). He has authored more than 400 publications (articles contributed to scientific journals, book chapters, books edited).
He served as External Examiner for the Second Professional Examination 2009/2010 of the Faculty of Medicine at the Chinese University of Hong Kong. He received the following awards: Ludolf-Krehl prize of the S.W. German Society for Internal Medicine in 1971, the IATDMCT Award, Cairns (Australia) 1999, the IATDMCT Charles Pippenger Award for Outstanding Contributions to Therapeutic Drug Monitoring, Washington (USA) 2001, the 2002 Canadian Society of Clinical Chemists Travelling Lectureship Award, the Professor-Landbeck-Award of the Society for Thrombosis and Hemostasis Research, Hamburg (Germany) 2004, the Perth PathCentre Visiting Lectureship, Western Australia 2004, the Honorary Fellowship of the Faculty of Pathology of the Royal College of Physicians of Ireland (FFPath RCPI), Dublin 2006, the Honorary Membership of the Romanian Society of Laboratory Medicine, Sibiu 2007, the WASPaLM Medal of Honor, Las Vegas (USA) 2011, the membership of the Bulgarian Academy of Sciences and Arts (BASA), Sofia 2012, the WASPaLM Gold Headed Cane, Quebec City (Canada) 2013, and the IATDMCT Honorary Membership, Salt Lake City (USA) 2013.
Research Advocate USA
Jack Whelan is an eight year survivor of a rare, incurable blood cancer moving from a career IT Research Analyst to Research Advocate; he was recently diagnosed with an aggressive form of metastatic prostate cancer for which he is in treatment. Travel with Jack on an intensely personal and often humorous bumpy ride on the road to Personalized Medicine which is still under construction as he participates in seven Clinical trials. Using business communications and research skills coming from his career as a Wall Street Research Analyst and career Sales VP in IT, he now helps bridge the communications gap between life sciences, medical professionals and patients. Jack hopes all appreciate the real value and noble work of life sciences employees and companies involved in cancer research and care. A decided friend to BioPharma and CROs as an engaged, informed e-Patient Opinion Leader (POL) and Advocate he regularly speaks to and for these companies, to open much-needed communications lines with patients, providers and policymakers. He encourages all patients to explore novel targeting agents and immunotherapies many of which are now in Clinical Trials. Using genetic and genomic information to develop new disease-specific targeted therapeutics might be safer and more effective treatment than conventional chemotherapy.
Jack’s a frequent speaker and participant at the best industry and advocacy conferences in the Americas and Europe sharing his engaging, gripping, hopeful and fun story about survival. Jack understands the realities of his blood cancer as he has repeatedly relapsed and has been refractory to most of the therapies received thus far; however his goal is repeated periods of progression free survival during which the promise of science and delivery of successful therapeutics will be achieved. His website is located at Jack-Whelan.com
Other information of potential interest:
In advocacy he’s an active member with AACR, ASCO, DIA, LLS, RDLA, NORD, NIH’s NCTN, ACRES and Transcelerate as Patient Advocate focused on Clinical Trials. He lives in Andover Massachusetts with his wife Jan, has three ‘fabulous’ daughters and sons-in-law and proud grandparents of six grandkids four of whom are twins He’s an associate member of the American Association for Cancer Research (AACR), completed the 2013 and 2014 Scientist-Survivor Programs and Science of Cancer Disparities in Research program, featured cover story of AACR’s Cancer Today Magazine, the AACR Annual (2014) Cancer Progress Report and appears in one of AACR’s national network TV fundraising commercials. He was a speaker at AACR’s 2015 and 2016 Annual Meeting. As a strong proponent of rational funding for biomedical research and to convince Congress to make this a national priority he will participate in his third AACR-led Rally for Medical Research this Sept ’16. Jack has been an event speaker for and is a strong supporter of AACR Foundation. He serves on the editorial board of AACR’s Cancer Today Magazine.
He is also active with the American Society of Clinical Oncology (ASCO), completed the Research Advocacy Network Focus on Research Scholars in conjunction ASCO’s Patient Advocacy Education Programs in 2013, 2015 and 2106. He serves on ASCO’s Patient Advisory Committee advising and promoting ASCO’s CancerLinQ EHR development programs. He is also active with and completed the Drug Information Association (DIA) Patient Advocate Fellowship Program in, has produced educational videos & webcasts for DIA. Jack is a keynote speaker and Co-Chair of the Research Advocacy Council of the Alliance for Clinical Research Excellence and Safety (ACRES) and member of the Patient Advisory Board at Transcelerate, both organizations are strong proponents of improving the Clinical Trials industry.
He’s an active volunteer with the International Waldenstrom’s Macroglobulinemia Foundation (IWMF) a charitable advocacy that provides patient education, support and funds research. He is IWMF’s New England Support Group Leader and a keynote speaker at IWMF’s Annual Educational Patient-Physician Forum.
He's active with Leukemia & Lymphoma Society (LLS) as speaker recruiting for LLS’ Team in Training and Light the Night, a First Connection patient advocate; he’s a speaker at local LLS’ support groups. He received the LLS’ 2014 Quality of Life Award and a 2016 Fight Against Blood Cancer Award. As a Legislative Advocate with LLS, he helped convince state lawmakers to pass the much-needed Oral Chemotherapy Parity bill, by participating in lobbying efforts at the state house, writing stories for print and broadcast press, and conducted email and phone call campaigns to help educate lawmakers. He is also a champion for new legislation centered on Biosimilars clarification, Step Therapy and Specialty Tiers bills.
With the Rare Disease Legislative Advocacy (RDLA) and National Organization for Rare Disorders (NORD) he has appeared before several Congressional delegations; he helps educate Federal lawmakers about much-needed legislation to encourage more funding for biomedical research and effective, efficient & up-to-date healthcare policies.
For the past several years, Jack has been a fundraiser and volunteer spokesman on radio and TV with the Jimmy Fund and Boston Red Sox for the benefit of Dana Farber Cancer Institute (DFCI). He is featured in a national TV commercial about his treatment at DFCI. Jack is a former Co-chairman of DFCI's Patient Family Advisory Council (PFAC). He served on the Institute’s Patient Advisory Committee on the Epic EMR system upgrade program.
Described as "a one man band with a loud drum to engage and motivate others", with a busy 2016 calendar, you may find Jack speaking at advocacy, healthcare, medical education and Life Sciences professional events around the United States and Europe. Jack is a graduate of the University of Rhode Island and United States Navy veteran.
R&D and Medical Affairs Consultant, Switzerland
Dr. Platon has been born in Bucharest, Romania in 1963. After his A Level in Bucharest he relocated to Germany in 1983 where he obtained the German Matura and studied Medicine in Cologne, London and Beer-Sheva. In parallel to his Conferral of Doctorate in Surgery he worked as a physician in the Department of Internal Medicine in Cologne, Germany.
Since 1994 Dr. Platon had different national and international, operational and executive medical positions in the Pharmaceutical, Medical Devices and Clinical Research Organization industry in Germany, USA and Switzerland. A special focus was addressed to Medical Affairs, Clinical Development & Operations and Pharmacovigilance (incl. QPPV). Stations of his professional life were Schwarz Pharma, Hoffmann-La Roche, Abbott, PharmaPart, Solvay and Alexion.
Dr. Platon is married, has three children and lives in Basel, Switzerland where he works as strategic and operational consultant in R & D and in Medical Affairs.
Sef de Sectie la Institutul National de Boli Infectioase Prof Dr Matei Bals Bucuresti
Dr Victoria Arama este medic primar - Sef de Sectie la Institutul National de Boli Infectioase Prof Dr Matei Bals Bucuresti, avand titlul de Profesor universitar la UMF Carol Davila Bucuresti, Facultatea de Medicina, Disciplina de Boli Infectioase - Matei Bals.
Domeniile sale stiintifice de interes sunt reprezentate de: Infectiile virale (virusuri herpetice, virusuri hepatitice, infectia HIV/SIDA, virusuri gripale, papilomavirusuri); Terapia antivirala; Vaccinologia ; Rezistenta bacteriana la antibiotice; Infectiile in sarcina; Infectiile la imunodeprimati; Infectiile fungice si terapia antifungica.
In ceea ce priveste activitatea de cercetare stiintifica, Prof Dr Victoria Arama a fost coordonator stiintific sau membru in echipa de cercetare a numeroase granturi stiintifice castigate prin competitii nationale si internationale, precum si investigator principal in peste 40 de trialuri clinice internationale.
Din punct de vedere al activitatii stiintifice, Prof Dr Victoria Arama este autor a 4 monografii stiintifice si a peste 40 de capitole in alte monografii. Este membra a numeroase societati stiintifice nationale si internationale (ISID, ECCMID, EASL, GEEP, IHMF) si a publicat ca autor / coautor peste 500 lucrari stiintifice in reviste medicale din tara si strainatate.
Prof Dr Victoria Arama este membra in Comitetul Stiintific al revistei medicale franceze Medecine et Maladies Infectieuses si membra in Comitetul Editorial la alte 7 reviste medicale romanesti recunoscute.
Municipal Clinical Hospital "Railway" of Moldova, Chishinau (Moldova)
Medicines and Medical Devices Agency, Medicines authorisation department, Chishinau (Moldova)
authorisation of medicines
Medicines and Medical Devices Agency, Clinical Trials Research Department, Chishinau (Moldova)
Head of Clinical Trials Research Department
Medicines and Medical Devices Agency, Chishinau (Moldova)
member of working group within the MMDA for centralized procurement
Medical doctor, Pharmacovigilance trainer
Center of Health Policies and Studies of Republic of Moldova, Chisinau (Moldova)
Pharmacovigilance in introduction of new anti TB products
Clinical Trials according to GCP
Arensia Exploratory Medicine GmbH, Chishinau (Moldova)
master-calss – Quality assurance and control in clinical trials
The State Expert Center of the MoH of Ukraine, Kyiv (Ukraine)
GCP Training for Investigators
Hoffman la Roche, Chishinau (Moldova)
participant of the 4-th scientific and practical conference with international participation „Clinical trials of medicinal products in Ukraine
The National Academy of Medical Sciences of Ukraine, Kyiv (Ukraine)
12/10/2012 “Основы международной регистрации лекарственных средств”
Vialek Ukraine, Chishinau (Moldova)
„Synevo 2012 – Conference for Clinical Trials”presentation „Challenges in conducting clinical trials in
the Republic of Moldova, Bucharest (Romania)
25/06/2013–26/06/2013 Cerificate of completion: Introduction to the Clinical Drug
Development Process: ICH Good Clinical Practice for Clinical Trials
Quintiles Global Talent, Development and Engagement, Chishinau (Moldova)
23/10/2013–25/10/2013 Training course
Practical GCP Compliance Auditing of Trials and Systems, London (United Kingdom)
16/03/2013 GCP Refresher Training
Arensia Exploratory Medicine, Chishinau (Moldova)
18/04/2013–19/04/2013 6-th Annual CIS and SEE Clinical Trials
Fleming Europe, Zagreb (Croatia)
05/2013 The training of internal auditors and managers in the standards
system in SM SR EN ISO 9001:2011; SM SR EN ISO/CEI
17025:2006 and SM SR EN ISO 19011:2012
National Institute of Standardization and Metrology Moldova, Chishinau (Moldova)
scientific-practical conference MoldMedizin 2013 in the exhibition "Rational use of medicines ",
development project "Strengthening the Moldovan pharmaceutical sector and Medical Devices
Agency for Medicines and" Speaker "Clinical Trials in Moldova" and "Marketing Authorisation
procedure in Moldova", Tartu (Estonia)
18/03/2015 Экспертиза регистрационного досье в формате СТD Модуль 1-3
Vialek, Chishinau (Moldova)
29/02/2016–01/03/2016 Participant work-shop HINARI- health research
MoH, Moldova and WHO, regional office for Europe, Chishinau (Moldova)
Synevo Central Lab Country Director Romania, Republic of Moldova, Bulgaria & Serbia
Cristina Florescu-Moraid is responsible for Synevo Central Lab’s operations in Romania since 2005. Cristina Florescu-Moraid was responsible for management of more than 80 studies and was involved in another 100 projects prior to her manager career. Cristina Florescu-Moraid got her Medical Doctor Diploma in 1997 from Carol Davila University of Medicine and Pharmacy in Bucharest, Romania and was accredited as Laboratory Medicine Specialist in 2005 and as Senior Laboratory Medicine Specialist in 2011, by the Romanian College of Physicians.
Dr. Florescu Moraid got her Master of Science Diploma in 2006 from Health Insurance National House and accomplished Postgraduated School of Clinical Trials Management at Gdansk Foundation for Management Development Gdansk in 2012. She graduated the Postgraduated Leadership Development Programme at University of Sussex, UK in 2014.
She is invited speaker for laboratory medicine and clinical research scientifc events and organize several courses and trainings for specialists working in clinical trials field.
Dr. Florescu-Moraid has more than 10 years of experience in laboratory and clinical trials industry now.
Director of Synevo Central Lab since 2009 and Synevo Polska laboratory since 2014
Dr. Tomasz Anyszek is Director of Synevo Central Lab since 2009 and Synevo Polska laboratory since 2014.He is responsible for clinical trials operations in more than 40 laboratories in Central and Eastern Europe. Dr. Anyszek started his career with Virtual Central Laboratory, Netherlands in 2000 (Covance VCL since 2003) and his experience also includes the coordination of 16 regional Covance partner laboratories in Europe. During this period he performed 200 audits in clinical laboratories. Dr. Anyszek holds his PhD from Jagiellonian University, Poland. Prior to his business career, he taught clinical biochemistry and laboratory medicine at the Jagiellonian University medical faculty. Dr. Anyszek has authored more than 20 scientific publications and co-authored several books and monographies in the clinical chemistry and laboratory medicine area.
He is invited speakers for many conferences held in laboratory medicine and clinical research area.
He is married and has two daughters.
Clinica de Medicina Interna, Institutul Clinic Fundeni, Bucuresti
Am absolvit Facultatea de Medicina Generala din cadrul Universitatii de Medicina si Farmacie Carol Davila Bucuresti in anul 1996.
In anul 2000 am obtinut titlul de medic specialist medicina generala, din 2005 - medic specialist medicina interna, iar din 2012 – medic primar medicina interna.
Angajat al Clinicii de Medicina Interna, Institutul Clinic Fundeni, din 2001 ca asistent cercetare stiintifica medicina interna, iar din 2007 ca cercetator stiintific.
In anul 2008 am obtinut titlul de Doctor in Medicina cu lucrarea: Factori predictivi ai raspunsului la tratamentul antiviral in infectiile cronice VHB si VHC (sub coordonarea Dlui Prof. Dr. Lucian Buligescu).
In prezent sunt membru al Subcomisiei de Hepatologie din Ministeul Sanatatii si Coordonator Secundar de Cercetare in Institutul Clinic Fundeni.
Din punct de vedere al activitatii stiintifice:
- peste 150 prezentari orale si sub forma de poster la simpozioane si congrese nationale si internationale - peste 40 articole publicate in reviste de specialitate;
- investigator principal sau subinvestigator in peste 25 studii clinice de faza II, III si IV';
- membru in Comitetul Executiv al Asociatiei Romane pentru Studiul Ficatului;
- membru al Asociatiei Romtransplant, al Societatii Romane de Gastroenterologie, Hepatolgie si Endoscopie Digestiva si al Societatii Romane de Medicina Interna;
- membru in comitetul de redactie al revistelor Journal of Translational Medicine and Research si The Lancet Oncology, editia romana.
CEO Center for Innovation in Medicine, Romania
Co-founder of the Center for Innovation in Medicine. National Task Force Manager for România of Public Health Genomics Network. Expert on the European personalized medicine Development Platform Member of the European Alliance of Personalized Medicine Participant IT Future of Medicine project Founder and general manager of specialized medical communication Kol Medical Media Editor- Chief of the journal Hippocrates, the medical community reference brand in Romania.
Secretar al Societății Române de Medicină Nucleară și Imagistică Moleculară
Am urmat cursurile de pregătire a Facultății de Medicină Generală din cadrul Universității de Medicină și Farmacie “Carol Davila” București între 2006-2012, iar din 2013 am început specializarea în Medicină Nucleară sub îndrumarea coordonatorilor de la Spitalul Universitar de Urgență Militar Central “Dr Carol Davila”. Din aprilie 2016 sunt angajată la Institutului Național de Endocrinologie “CI Parhon” București în Departamentul de Medicină Nucleară, Compartiment Cronici-Terapie Izotopică. În iunie 2015 am devenit secretar al Societății Române de Medicină Nucleară și Imagistică Moleculară. Din iulie 2015 am început să lucrez la proiectul “BIOMAT-ENDO: construcția bazei de date digitale pentru monitorizarea pacienților cu cancer tiroidian”. Acest proiect urmărește să digitalizeze informațiile cu ajutorul unui software tip "baza de date" , urmat de etapa pregătirii acestor date pentru analiza lor prin metode de statistica matematica. O parte din parametrii de interes sunt: zona geografică de proveniență a pacienților cu cancer tiroidian, vârsta actuală a pacienților, sexul, debutul bolii, factori genetici, tipul intervenției chirurgicale inițiale, dar și a reintervențiilor, rezultatul anatomo-patologic, doza totală terapeutică de 131I, valorile marker-ilor tumorali sau hematologici, precum și altele. Din punct de vedere al activității științifice sunt încă la început de drum, dar am participat cu lucrări la mai multe conferințe și congrese naționale și internaționale de profil.