Monday, 13th October 2014 - Villa Forno Breme, Cinisello Balsamo (Milan)
In the recent years, clinical observational research has become an essential tool for the development and spread of new health technologies, particularly in the pharmaceutical field.
Within the health systems, the need of a well-documented platform for planning and decision-making is growing and therefore collecting real world data is receiving more and more attention, becoming more and more a strategic choice. According to a recent survey published by the European Commission, an increasing number of countries revisited the relative efficacy and effectiveness of a new treatment as a part of their decision making process for reimbursement and pricing, addressing consistent value to data generated within effectiveness assessment.
As decisions must be taken on an evidence-based foundation where all relevant circumstances and consequences are systematically framed by means of scientific methods, it is essential to put in perspective the data collected under real life practice circumstances.
Due to the many possible study designs in observational research, the proper design is needed to address and answer very different questions:
• descriptive clinical epidemiology
• post-marketing safety studies (PASS)
• comparative effectiveness research
• evaluations on appropriateness of health care interventions, and many others.
This year the 4th EPIFORUM will focus on the use of epidemiological methods in providing real world evidence (RWE) to document product value in pre and post marketing activities.
This event aims to bring together experts not only from the world of clinical research but also from academia, public institutions and industry to exchange views and experiences among all the participants, providing networking opportunities and adequate discussion between speakers and audience.
Giovanni Corrao, Dept Statistics & Quantitative Methods, Division of Biostatistics, Epidemiology & Public Health, University of Milano-Bicocca, Milan
Stefano Viaggi, Director of Marketing and Real World Data Solutions, MediData Observational Research
Thomas Zwingers, Senior Director, Consultancy Services, CROS DE GmbH
The event is addressed to Professionals with a deep interest in drug development and healthcare decision making such as:
Medical Director, Managing Director, Medical Affairs Director, Medical Informatics, R&D Manager, Pharmacovigilance manager, Clinical Operation Manager, Clinical Research Associate, Clinical Project Manager/Clinical Project Leader, Statisticians and Data Managers.
Belonging to Pharmaceutical and Biotechnology company, CROs and University/Hospital, academic research, patient associations, healthcare organisations.