Pre-Conference Tutorials, Monday, March 8, 2010, 09:00

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36 Theme 11 This is a preliminary programme. New speakers and sessions will be added. Visit www.diahome.org for the most recent additions to the programme. 16:00 Session 1005 ARE INFORMED PATIENTS COST-EFFECTIVE? HOW TO ENSURE THAT PATIENTS UNDERSTAND THE DECISIONS BEING MADE ON THEIR MEDICINES Session Chair: Jean Mossman, Consultant and Policy Advisor to European Federation of Neurological Associations (EFNA), UK The aim of the session is to look at how patients can understand decisions made on their medicines after the product has reached the market. One area to be considered is how patients can understand and contribute to the decisions being taken by the Heath Technology Assessment bodies on whether a medicine will be made available through a country's healthcare system. An additional area to look at is where patients can add to the knowledge gathered on the safety of a medicinal product and the analysis of that knowledge as the product is used in a population wider than that used for clinical evaluation. Can Regulatory Authorities Take Account of the patients’ Needs in their Decisions? How do Regulatory Authorities consider the Patient’s Need for Efficacy rather than the Consumer’s Need for Safety? Isabelle Moulon, Head of Medical Information, European Medicines Agency, EU Understanding How Decisions Are Made about Reimbursement: The role of patients in health technology assessment Guiseppe La Torre, Associate Professor Clinical Medicine and Public Health Unit, Sapienza University of Rome, Italy Supporting Individual Patients in Decisions about their Medicines: How can patients be more involved in decisions about which drugs are available? Anita Waldmann, President, Myeloma EuroNet, Germany Wednesday, March 10, 2010 09:00 Session 1006 HOW INVOLVED CAN INFORMED PATIENTS BE IN THE DEVELOPMENT AND COMMERCIALISATION OF MEDICINES? Session Chair: Cecilia Potez, Director, EU and International Regulatory Policy & Intelligence, AstraZeneca, UK Citizens and society in the modern world take a more active interest in healthcare issues than was traditionally the case. They increasingly wish to be more involved in development decisions but how much input to the decisionmaking will industry relinquish, particular when making determinations on clinical endpoints and PROs. Is drug development really meeting the needs of patients and society? European Medicines Agency View Isabelle Moulon, Head of Medical Information, European Medicines Agency, EU Sylvia Lion, Director, Global Advocacy & Professional Relations, Endocrinology, Lilly, France Patient View Mary Baker, MBE, President of European Federation of Neurological Associations (EFNA), UK 11:00 Session 1007 PATIENT USE OF INFORMATION ON MEDICINAL PRODUCTS Session Chair: Anders Olauson, President, European Patients’ Forum, Sweden The overall aim of the session is to look at how patients use currently available information. In particular, looking at how patients use information that they get from healthcare professionals, fellow sufferers, providers of the treatment and other sources. This session will have a greater focus on diseases that affect the wider society (e.g. oncology, stroke, diabetes etc). Session under development 14:00 Session 1008 WHAT INFORMATION DO PATIENTS WANT ON MEDICINAL PRODUCTS AND HOW FAR DO THE CURRENT PROVISIONS GO TO MEET THESE NEEDS? Session Chair: Mary Baker, MBE, President of European Federation of Neurological Associations (EFNA), UK Different patients have different information needs depending on many factors including the condition itself, the stage of the condition and the patient themselves. This session will look to ask the question whether the information that a patient needs and wants is already available - they just need to know where to find it. Provision of Patient Information by the Pharmaceutical Industry – The Hamlet approach “To Trust or not to Trust” Alastair Benbow, Senior Vice President and Head of Global Clinical Safety and Pharmacovigilance, GlaxoSmithKline, UK Patient View Nikos Dedes, Chair, Policy WG, European AIDS Treatment Group, Greece Patient Information, The Case for Anarchy Richard Smith, Chairman of the Board of Directors, Patient Knows Best, UK Theme 11 eHealth Theme Leaders: Valdo Arnera, General Manager, Europe, PHT Corporation, Switzerland Pierre-Yves Lastic, Senior Director, Data Privacy & Healthcare Interoperability Standards, sanofi-aventis, France The influence of technology on healthcare and clinical development has seen an unprecedented growth in recent years. This theme intends to cover the value brought by these new technologies, whether these have been used for a while, like EDC or ePRO, or whether they are emerging or still a vision of what they could bring to the way we will develop drugs and treat patients in the next 10 years. Monday, March 08, 2010 16:30 Session 1101 THE NEW IT ARCHITECTURE FOR MEETING THE CHALLENGES OF eHEALTH Session Chair: Pierre-Yves Lastic, Senior Director, Data Privacy & Healthcare Interoperability Standards, sanofi-aventis, France The acceleration of the adoption of Electronic Health Records (EHR) all over the globe has pushed the pharma R&D to start to look at ways of allowing patient eData to be used in clinical trials. Countries like the Scandinavian countries, the UK or Netherlands have been paving the way to adopt EHR in their respective countries, needing the implementation of national Heath IT infrastructures that will be presented. Also, in the US, the FDA has requested more and more data to be submitted in an electronic format, and the new FDA IT architecture wil also be presented. How to Use Pharma Architecture to Optimise R&D John Aggerholm, Project Director, HERAX A/S, Denmark The eSource Regulatory Point of View Fergus Sweeney, Head of Compliance and Inspections, European Medicines Agency, EU
This is a preliminary programme. New speakers and sessions will be added. Visit www.diahome.org for the most recent additions to the programme. The New NCI IT Architecture Charles Mead, Senior Director, Healthcare and Life Sciences Strategy, Booz Allen Hamilton, Chief Technology Officer, NCI, USA Tuesday, March 09, 2010 09:00 Session 1102 PATIENT AND CLINICIAN REPORTED OUTCOMES USE IN GLOBAL MEDICAL PRODUCT DEVELOPMENT: AN UPDATE ON INDUSTRY BEST PRACTICE AND REGULATORY ISSUES Session Chair: John Weiler, President, Compleware Corporation, USA Clinician rated or reported outcomes (ClinROs) have historically been the basis for labelling claims, but both the European Medicines Agency and the FDA have acknowledged the importance of patient reported outcomes (PROs) and, increasing, new medical products are being approved based on PROs as well. Regardless of the type of study endpoint used, outcomes need to be valid and reliable and collected with integrity. It is critical that clinical trial sponsors ensure the content validity of ClinROs and PROs. In addition, if the study endpoint is collected electronically, steps must be taken to ensure measurement equivalence. This session will detail the important content validity issues; discuss study endpoint validation study designs and case studies; and share the associated regulatory perspective. The audience will gain an understanding of today’s regulatory considerations and industry best practice for PROs and ClinROs. Regulatory Perspectives when PROs and ClinROs are Deployed Laurie Burke, Associate Director, Study Endpoints and Labeling Development, Office of New Drugs, CDER, FDA, USA Content Validity: Issues in the Development of Instruments Jane Scott, Research Director, MAPI Values, UK Leveraging Technology and Ensuring Measurement Equivalence for PROs and ClinROs Keith Wenzel, Senior Director, Product Management, Perceptive Informatics, USA 11:00 Session 1103 EDC CASE STORIES Session Chair: Julianne Hull, Senior Director, Global Development Data Operations, Pfizer, UK If 2007 has been the year when, for the first time in clinical trials history, the use of eCRF has taken over the use of paper, there is still a lot of room for improvement in the use of Electronic Data Capture and associated etools. Development of new drugs implies more than ever before, the participation of multiple countries and sites around the globe which raises new challenges. This session will include case studies and various experiences presented from pharma as well as the Contract Research Organisation (CRO) industry. EDC - The Tool to Enable Speedy Decision Making Mireille Zerola, Data Management Specialist III, Boehringer Ingelheim, Ltd., UK Pros and Cons of Different EDC Tools in Different Scenarios with Focus on Enabling Speedy Decisions Thomas O’Leary, Vice President, Clinical Data Management, ICON plc, Ireland Accelerate Decision Making Through Real Time Dictionary Coding Douglas Burgener, Product Manager Data Management Solutions, Perceptive Informatics, USA Theme 11 - Theme 12 14:00 Session 1104 EMERGING TECHNOLOGIES FOR OPTIMISATION OF PATIENT TREATMENT Session Chair: Valdo Arnera, General Manager, Europe, PHT Corporation, Switzerland If the use of "e" is increasing in the clinical trials arena, we can also start to see the benefits of using technology in "standard" patient care, including but not only in the EHR domain, allowing better follow-up and better treatments, as well as often reducing the cost of therapies. This is the real future of eHealth where telemedicine for example could translate into better and cheaper medical care for every patient. This session will present some case studies in western countries but also describe the efforts put in place to give access to EHR in emerging nations. An eHealth Project Providing Integrated Care and Risk Management for Coronary Disease with Direct Patient Communication through an EDC system Claus Lindenau, Head, Business Development, XClinical GmbH, Germany How to Prevent COPD Exacerbation Using an eDiary Gerard Criner, Pulmonologist, Professor, Temple University Medical School, USA Joint Effort for Providing eHealth Technologies to Emerging Nations Charles Jaffe, CEO, HL7, USA 16:00 Session 1105 IMPROVING DRUG SAFETY THROUGH THE USE OF NEW TECHNOLOGIES Session Chair: Sabine Brosch, Scientific Administrator, Pharmacovigilance and Risk Management, European Medicines Agency, EU Drug safety monitoring can be considerably improved through the use of new technologies. This session provides insights into these new possibilities from different point of views Evaluating Drug Safety and Effectiveness through the Lens of eHealth Data Wayne Kubick, Vice President, Phase Forward Lincoln Safety Group, USA Integrated Web-Based Tools Supporting Regulatory Bodies: From clinical trial national registries to the post- marketing safety surveillance tools Marisa De Rosa, Head of Systems and Services for Health Department (SISS), CINECA Inter-University Consortium, Italy FDA View Stephen Wilson, Director, Division of Biometrics III, CDER, FDA, USA Wednesday, March 10, 2010 09:00 Session 1106 HEALTHCARE INTEROPERABILITY STANDARDS Session Chair: Wolfgang Summa, Executive Vice President, Business Development, OmniComm Systems, Germany With the involvement of Standards Development Organisations such as ISO, CEN, HL7, CDISC and IHTSDO, the development of international standards for the monitoring of drug safety has taken a new dimension. After a short introduction on how these standards are currently being developed and how they relate to each other, this session will provide an overview of the newly developed standards, followed by a panel discussion with European Medicines Agency and industry speakers. What’s New about Standards? A General Overview Pierre-Yves Lastic, Senior Director, Data Privacy & Healthcare Interoperability Standards, sanofi-aventis, France 37
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