BIG DATA Driving Evidence for Healthcare Thursday, 5 March :30 17:45 Lecture Hall Pathology C

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1 Symposium of the Swiss-Austrian ISOP Chapter International Society of Pharmacovigilance BIG DATA Driving Evidence for Healthcare Thursday, 5 March :30 17:45 Lecture Hall Pathology C

2 Program: Thursday, 5 March 2015, Zurich 13:00 Registration Desk Open Session I (13:30 15:30) Session Chair: Jan-Willem van der Velden (Mesama Consulting, Bözberg) Mario Bertazzoli (Helsinn, Lugano) 13:30 Welcome and Introduction: Big Data Driving Evidence for Healthcare Stefan Russmann (University Hospital and ETH Zurich, Switzerland) 13:50 Big Data Real-life Studies and Available Databases with Focus on PASS Susana Perez-Gutthann (RTI Health Solutions, Barcelona, Spain) 14:20 Epidemiological Research Using Big Data Promises and Pitfalls Peter Jüni (University of Berne, Switzerland) 14:50 Big Data Research on the Benefi t-risk Evaluation of Therapies in Multiple Sclerosis Madé Wenten (Biogen Idec, Boston, USA) Followed by Open Discussion 15:30 Coffee Break Session II (16:00 17:20) Session Chair: David Niedrig (University Hospital and ETH Zurich) Olesya Zorina (Boehringer-Ingelheim, Ingelheim, Germany) 16:00 Solutions for Medical Quality Management André Sander (ID Berlin, Berlin, Germany) 16:30 Big Data Real-time Analyses Bringing Business Intelligence and Healthcare Together Luzi Zappa (4solutions, Zug, Switzerland) 17:00 Adverse Reactions: Current and Future Reporting Requirements and Electronic Data Exchange Mario Bertazzoli (Helsinn, Lugano, Switzerland) 17:20 Review and Open Discussion, followed by board elections Plenum, ISOP chapter members 17:45 End of Symposium

3 Speakers Mario Bertazzoli (Lugano, Switzerland) Mario Bertazzoli is a physician and registered specialist in Human Reproduction Pathology. He received both medical and specialization degrees from the University of Milan, Italy. He worked as a physician for the Obstetric and Gynecological Department of the University of Milan and for the Italian National Health Service, district of Milan. Since 1995 he has been working for international pharmaceutical companies as pharmacovigilance and pharmacoepidemiology physician. Mario is currently Head of Corporate Drug Safety and Reference Physician to the EU Qualifi ed Person for Pharmacovigilance for the Helsinn Group and Treasurer of the International Society of Pharmacovigilance, Swiss-Austrian Chapter. Peter Jüni (Berne, Switzerland) Peter Jüni is Professor of Clinical Epidemiology and the Director of the Institute of Social and Preventive Medicine and of CTU Berne, the University Hospital s clinical trials unit. He is primary investigator, methodologist in charge or member of the steering group of major clinical studies and collaborative analyses in the musculoskeletal and cardiovascular fi eld and contributes to clinical studies, meta-analyses and methodological research in other fi elds. Susana Perez-Gutthann (Barcelona, Spain) Susana Perez-Gutthann, MD, MPH, PhD, FISPE, FRCP, leads a team of over 30 epidemiologists and research staff, including senior experts, in the fi eld of pharmacoepidemiology and risk management in RTP (NC, US), Waltham (MA, US), and Barcelona (Spain). Prior positions include global and European head of epidemiology at Pfi zer, Pharmacia, Novartis, and Ciba-Geigy. Dr. Perez-Gutthann has over 24 years of experience leading epidemiology teams, and strategy and research programs for safety, pharmacovigilance, risk management, and drug development. She is an active leader and past president of the International Society of Pharmacoepidemiology (ISPE); a Fellow of ISPE and of the Royal College of Physicians, Edinburgh; and represents RTI Health Solutions at the European Network of Centers for Pharmacoepidemiology and Pharmacovigilance, where she has served as member of the steering group since Dr. Perez-Gutthann is the principal investigator of studies and serves as chair or member of advisory boards in pharmacoepidemiology and risk management.

4 Speakers Stefan Russmann (Zurich, Switzerland) Stefan Russmann, MD, is Head of Pharmacoepidemiology and Drug Safety at the Department of Clinical Pharmacology, University Hospital Zurich, president of the Swiss-Austrian ISOP Chapter, and board member of the Swiss Society for Drug Safety in Psychiatry (SGAMSP). He setup a pharmacovigilance center and Clinical Investigation Unit conducting phase I to III clinical trials at the University Hospital Berne. Stefan specialized in pharmacoepidemiology with the Boston Collaborative Drug Surveillance Program (BCDSP) in Boston, MA, and was Medical and Research Director at the Degge Group in Arlington, VA. He teaches clinical pharmacology and pharmacoepidemiology at the University of Zurich, the Federal Institute of Technology Zurich (ETHZ), and he is also Adjunct Associate Professor of Epidemiology at Boston University, MA, USA. André Sander (Berlin, Germany) André Sander has a degree in engineering and information technology and is head of software development at ID Berlin. He has been working with ID for 17 years and currently manages a group of about 30 software engineers. His main focus lays on terminology based software systems. In the early 2000s he developed the fi rst search algorithm that was fully based on a medical semantic network. Since then, this system has dramatically evolved and is now used by more than 1200 hospitals in 6 countries. Madé Wenten (Boston, USA) Madé Wenten is Director of Epidemiology at Biogen Idec, based in Cambridge, MA, USA. He received his Doctoral training in Epidemiology at the University of Southern California and earned graduate degrees in both Applied Statistics and Health Education. In his role at Biogen, he leads research initiatives to explore MS disease progression, and to understand the benefi t-risk profi le for the marketed MS therapies. As such, he conducts research with academic institutions, healthcare delivery systems, and contract research organizations. He utilizes various big data assets, of which Biogen has licensed, as one of many tools to conduct this research. Luzi Zappa (Zug, Switzerland) Luzi Zappa obtained his degree in economical sciences and accounting from the University of Zurich (lic. oec. publ. MBA). He has over 25 years of experience in the area of fi nancial consolidation and management reporting systems for international clients and has worked for an American consulting company. He is a founding partner of 4solutions gmbh, providing special expertise and services for business intelligence, reporting and decision support systems. 4solutions has over 75 clients worldwide especially implementing fi nancial and management reporting in various business areas, including healthcare.

5 Meeting Information Organization PD Dr. med. Stefan Russmann, MD UniversityHospital Zurich Department of Clinical Pharmacology and Toxicology Rämistrasse Zürich Switzerland Location UniversityHospital Zurich Lecture Hall Pathology C (Main Entrance) Rämistrasse Zürich Switzerland How to get there By car Only limited car parking near the Hospital. Public Transport Tramway no. 10 from Zurich Main Station. Tram stop ETH/Universitätsspital in front of the main entrance. Language English Credits 3 Credits SGKPT. 3 Credits SGPM. 25 Kreditpunkte für FPH Spitalpharmazie und Klinische Pharmazie. More information on Credits at Registration Online registration at Or send an with the header Registration ISOP ZH 2015, your name, affi liation and contact information to: isop.chat@intranets.ch Registration fee is 50,- CHF. Student rate is 25,- CHF, ISOP members are waived from registration fee. You will receive a confi rmation mail with payment information after you have registered. On-site registration is possible but subject to availability of seats, and we therefore recommend pre-registration via . Speakers Mario Bertazzoli (Lugano, Switzerland) mario.bertazzoli@helsinn.com Peter Jüni (Berne, Switzerland) juni@ispm.unibe.ch Susana Perez-Gutthann (Barcelona, Spain) sperez@rti.org Stefan Russmann (Zurich, Switzerland) stefan.russmann@usz.ch André Sander (Berlin, Germany) a.sander@id-berlin.de Madé Wenten (Boston, USA) made.wenten@biogenidec.com Luzi Zappa (Zug, Switzerland) luzi.zappa@4solutions.ch

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