A Pan-European Conference: Clinical Data Management 2010

A Pan-European Conference Clinical Data Management 2010 Recent global challenges of data management within clinical trials Maritim Hotel Berlin, Germany 23rd & 24th June 2010 Learn from Key Practical Case Studies: Sensitive markets and sensitive products call for an impeccable handling of sensitive data. • Clinical Data Management Organization: How to justify internal CDMs contribution to drug development • Referees in Clinical Trials: Strategies and Systems Supporting the Adjudication Process in Clinical Events Committees marcus evans Expert Speaker Panel: • EDC in a biotech-company – Does it work? Dr. Johann Pröve Stefanie Fischer • Improving data quality in the context of increasing Head, Global Data Management Vice President & Global Head, Clinical Data complexity of clinical trials Bayer Vital GmbH Management • Sponsors, CROs, Labors, Regulators interface SIRO Clinpharm Germany • STDM – Development and significant changes since Dr. Massimo Raineri commitment to implement CDISC Head of Systems Development – Biometry Hermann-Josef Huss • Clinical Data Management Organisation: The Actelion Pharmaceuticals Italis Head Global ClinPharm and NIS Data experience of a CROs' Network Management • Data Managers – The Next Generation Dr. Michael Hennig Bayer Vital GmbH • Integration between clinical and medical practise Head of Biostatistics / Data Management Fresenius Biotech GmbH MD PhD Olav Flaten Medical Director Plus: Panel Diskussion on Day One: Adrian Hsing GlaxoSmithKline A/S Proband of the future: A human being Senior Director Clinical Data Management or a mathematical data model? Gilead Sciences, Inc. Dr. Marco Bassano Data Management & Statistics Director Dr. Roman Bobrovsky Dimensione Ricerca S.r.l. Senior Manager, Clinical Data Management Early Bird Special Offer: Baxter Innovations GmbH Margarete Rudloff Book by 01.04.2010 and save 10% Director Clinical Data Management, Dr. Wolfgang Kuchinke Europe/Asia Pacific Clinical research and IT management Kendle In Association with: Coordination Centre for Clinical Studies (KKS) at University Duesseldorf Gail Kniveton Director of Data Services Dr. Wolfgang Eglmeier i3 Pharma Resourcing Head Clinical Operations Germany Grünenthal GmbH Media Partners: Co-operation Partner: conferences www.marcusevansde.com Speaker Profile Dr. Marco Bassano MD PhD Olav Flaten Ph. D. in Statistics at University “La Sapienza” (Rome) – in the 1996 MD and PhD University of Oslo. Hospital practice in internal medicine with Master Degree at the Amsterdam University (The Netherlands) – before joining the industry. Management training from INSEAD. Past Demographic Department. In 1999 started to work in the clinical Data and present member of numerous committees, expert teams both in Management and Statistics Department of Dimensione Ricerca (CRO) as academia and in industry nationally and internationally. More than 100 Biostatistician & Data Manager. Director of Data Management & publications covering aspects from medical science to business and Statistics department since Oct 2005. Responsible for all activities management issues. carried out in the Data Management & Statistics (DMS) department and acting as representative towards Clients (current and potential), opinion leader, investigators and Regulatory Authorities. Therapeutic Dr. Michael Hennig areas of research: Microbiology, Cardiovascular, Oncology, Neurology, studied and obtained his PhD in Statistics at University of Dortmund. Dermatology, Haematology, Reumatology, Psychiatry, Gastroenterology, He has been working for almost 20 years in the field of Biostatistics Gynaecology,etc. Study phases: I-II-III-IV, Observational, PASS (Post and Data Management; started as SAS-Programmer and project Authorisation Safety Study). Membership: SISMEC “Società Italiana di statistician at Boehringer Mannheim. At the Institute for Medical Statistica Medica ed Epidemiolgia Clinica” (Italian Society of Medical Statistics and Epidemiology (Klinikum rechts der Isar) he was Statistics and Clinical Epidemiology). Long-term computer skill in SPSS® responsible for setting-up and performing statistical services for the (Statistics); NCSS® (Statistics); SAS® (Statistics); nQuery Advisor® pharmaceutical industry and for other sponsors. Dr. Hennig joined (Statistics); Teleform® (Optical Character Recognition). Author and Fresenius Biotech in 2005 and built up the department of Biostatistics / collaborator in many scientific articles published in international Data Management. In this time he introduced EDC-processes for journals. various studies in oncology. He is a member of the DIA and IBS and published more than 60 papers, focussing on the application of statistical research. Dr. Roman Bobrovsky is Senior Manager of Clinical Data Management at Baxter BioScience in Vienna. He is responsible for global and EU based EDC studies with Adrian Hsing focus on vaccine trials and for SAS programming and standardization is Senior Director of Clinical Data Management at Gilead Sciences, Inc., for all Therapeutic Areas in BioScience. Roman graduated from the where he has implemented a virtual clinical data management concept Technical University of Vienna, where he obtained his PhD in Organic to improve clinical data management processes. He has also adopted Chemistry. He started his professional career as a database developer EDC for Gilead since 2001 and now more than 90% of Gilead studies before he joined Sanochemia Pharmazeutika AG in 1997, where he are done in EDC. In addition, Adrian is co-founder of IVRAS, a lead the chemical production unit in a GMP environment. In 2000 he company utilizing voice technology to improve clinical trial process. joined European Telecom International, the Austrian branch of the Adrian is also Chairman, Board of Directors at IVRAS. Prior to joining Spanish Telefónica in Austria, where he lead the Service Development Gilead, Adrian worked for Tufts University School of Medicine/New team. In 2002 he joined the Clinical Data Management group of Baxter England Medical Center Hospitals, PAREXEL, and Pfizer. He also has BioScience as a Data Manager. Since 2005 he is leading the newly served as co-principle investigator on Phase I oncology clinical trials. Mr. formed EDC group and directing Baxter's EDC efforts within a Hsing is a graduate from Tufts University Sackler School of Graduate comprehensive GCP environment. Biomedical Sciences and holds a M.S. in Molecular and Cellular Physiology. Dr. Wolfgang Eglmeier studied biology and physics. He obtained a PhD in neuroscience. Herman-Josef Huss Wolfgang is working in the area of clinical development since 1988. He Statistician, worked as statistitian in the industry since 1986, with started as CRA, monitoring studies in central and Eastern Europe. In Jansen, Boehringer Mannheim and Roche , as study, project statistician the early 90s he was with a software company, which developed data and global biometrics team leader and departmental head statistics at management and remote data entry software. Since 1993 he holds Roche. Thereafter joining Bayer for a position of European head of several management positions, mainly on a European level, in the Data Management in 2001, since 2007 responsible for global pharmaceutical industry, biotech companies and CROs. He has more Clinpharm Data Management.