EuroMEEting - Genetic Alliance UK

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40 THEME 14 This is the advance programme. New speakers and sessions will be added. Visit www.diahome.org for the most recent additions to the programme. how this evolution aligns with US and European strategy. Strategic Directions in the US: An industry perspective John Kiser, Senior Director, Global Submission Operations & Business Strategy, Global Pharmaceutical Regulatory Affairs, Abbott Laboratories, USA ‘E’ Strategy & the European Submissions Platform: A regulator perspective Regulator invited Regulated Product Standards and Alignment with European Strategy Geoff Williams, E-Regulatory Liaison, Roche Products Ltd, UK Wednesday, 30 March 2011 09:00-10:30 Session 0205/1405 IMPLEMENTATION OF THE REVISED VARIATIONS REGULATION – ARE THE OBJECTIVES BEING MET? (JOINT WITH THEME 2) Session Chair: Michael J. James, Head of CMC Regulatory Advocacy and Intelligence, Global Regulatory Affairs, GlaxoSmithKline, UK The revised Variations Regulation (EC No. 1234/2008) applied from 1st January 2010 to marketed authorisations granted through a mutual recognition process, decentralised procedure or centralised procedure. The overall objectives of this revision were to provide a simpler, clearer and more flexible legislative framework governing variations. Based on 15 months experience, industry and regulatory experts will provide a perspective on whether these objectives are being met. Specific considerations will be given to experience on procedural aspects, managing CMC changes, and implications for e-Submissions. The Revised Variations Regulation - Are the new ideas at life? Peter Bachmann, Senior Expert, European Drug and Regulatory Affairs, BfArM, Germany Implementation of the Updated EU Variation Regulation – Simpler, clearer and more flexible? Merete Schmiegelow, Director, Regulatory Intelligence, Novo Nordisk A/S, Denmark Challenges and Opportunities for E-submissions Remco Munnik, Regulatory Affairs Information Manager, Sandoz, B.V., The Netherlands 11:00-12:30 Session 1406 KNOWLEDGE MANAGEMENT: CULTURES, BEHAVIOURS AND ORGANISATIONS Session Chair: Raun S. Kupiec, Senior Director, Regulatory Affairs, Genzyme Europe, The Netherlands New standards, technology solutions and process initiatives are everywhere in pharma and the health sector. These initiatives promise to fundamentally alter the way we do business, improving quality and efficiency. However, dramatic initiatives and fundamental changes are nothing new (remember the paperless office that was around the corner 20 years ago?). How far have we come, where are we going, and what are the day-to-day implications for how we work in the organisational framework of drug development? Clinical Trial Registries – Where do we stand? Susanne Jena, Project manager, University Medical Center Freiburg, Germany Clinical Documentation Made Easy: Managing our eTMF using the DIA reference model Jascha Minow, Product Manager, Nextdocs Corporation, Germany System Validation: Is it fit for purpose? John Wise, Executive Director, The Pistoia Alliance, UK 14:00-15:30 Session 1407 SIGNAL DETECTION – MAKING USE OF AVAILABLE DATA SOURCES Session Chair: Wayne Kubick, Vice President, Phase Forward Lincoln Safety Group, USA This session will explain and explore the use of signal detection methods to improve the management of lifecycle product safety. The session will begin with a brief description of signal detection methods, and comprise case studies that discuss signal detection, management and evaluation using spontaneous report and observational data from the perspectives of a sponsor, regulatory authority and academic research organisation. Implementing Signal Detection Methodology in a Medium-Sized Company: Case studies review William Smedley, Director, PV Operations, Shire Pharmaceuticals, USA Signal Detection and Management from a Regulatory Perspective Peter Arlett, Head of Pharmacovigilance and Risk Management, European Medicines Agency, EU Signal Generation and Evaluation in Health Care Data – A case study using German claims data Marc Suling, Research Scientist, University of Bremen, Bremen Institute for Prevention Research and Social Medicine (BIPS), Germany 16:00-17:30 Session 1408 KNOWLEDGE MANAGEMENT: TECHNOLOGIES Session Chair: John Wise, Executive Director, The Pistoia Alliance, UK In the new global, IT-based knowledge economy, the possession of relevant and strategic knowledge and its unceasing renewal is fundamental for businesses to remain competitive. This session will provide real-world examples of companies successfully tackling this challenge as well as providing a glimpse into how state-of-the-art cloud computing might transform knowledge management in Clinical R&D. Using Social Media to Support Knowledge Sharing and Obtain Cost Savings - From strategy to action by understanding the users Erik Korsvik Ostergard, Principal Consultant, Manager, Novo Nordisk S/A, Denmark Knowledge Management Enablers - Operational and quality control centres Siegfried Schmitt, Principal Consultant, PAREXEL, UK Cloud Computing in Clinical Research & Development – Hype or opportunity? David A. Medina, Director, Worldwide Life Science & Pharma Segment Executive, Hewlett Packard Company, USA
THEME 15 41 This is the advance programme. New speakers and sessions will be added. Visit www.diahome.org for the most recent additions to the programme. Theme 15 | Pharmaceutical Development: Regional Perspectives Urszula Scieszko-Fic, Registration Director, Temapharm Sp. z.o.o., Poland Vincenzo Cannizzaro, International Regulatory Specialist, Qualitecfarma, Spain This theme will look at the opportunities within several regions of the world and help attendees understand what challenges these regions are facing. The Japanese Regulatory session which has been an extremely popular and valued session at the EuroMeeting for a number of years will be included in Theme 15. Tuesday, 29 March 2011 09:00-10:30 Session 1501 REGULATION SYSTEMS IN TURKEY Session Chair: Ahmet Araman, Dean, Faculty of Pharmacy, University of Istanbul, Turkey As an emerging market, the regulation system in Turkey will be discussed. EU Regulation Compliance Yasemin Karabey, Department Head, EU Regulations, MOH Drug and Pharmacy Directorate, Turkey Registration Process Yonca Iscan, Department Head, Bioavailability/Bioequivalence, MOH Drug and Pharmacy Directorate, Turkey Pharmaceutical Industry and Country Specific Conditions Melek Bostanci Onol, DRA Manager, Boehringer Ingelheim Ilac Ticaret A.S.,Turkey 11:00-12:30 Session 1502 MIDDLE EAST Session Chair: Kathrin Laubacher, Team Leader Training, F. Hoffmann - La Roche AG, Switzerland Issues from an HA Perspective Laila Ghazi Jarrar, Director General, JFDA, Jordan Work of a CRO in the Middle East Vladimir Misik, Senior Regional Director, Middle East Clin Ops, Quintiles, Austria Experience with Regulators in the Region Heba Hashem, Regional Regulatory Manager, Bayer Schering Pharma, Egypt 14:00-15:30 Session 1503 JAPANESE REGULATORY SESSION: PMDA UPDATE - INITIATIVES AND CHALLENGES FOR PROMOTING GLOBAL DRUG DEVELOPMENT Session Chair: Kyoichi Tadano, Director, Division of Planning and Coordination, PMDA, Japan Future Directions and Challenges of PMDA Tatsuya Kondo, Chief Executive, PMDA, Japan Current Status of New Drug Reviews and Challenges to Promote Global Drug Development Hideo Utsumi, Executive Director and Director, Center for Product Evaluation, PMDA, Japan Current Projects for Promoting Global Drug Development including Japan Yoshiaki Uyama, Review Director, Office of New Drug III, PMDA, Japan 16:00-17:30 Session 1504 AFRICA Session Chair: Jennifer Kealy, Managing Director, Cascade Clinical Consulting Ltd., France Session under development Wednesday, 30 March 2011 09:00-10:30 Session 1505 GLOBAL SIMULTANEOUS DRUG DEVELOPMENT AND GLOBALISATION OF DRUG DEVELOPMENT: FOCUSING ON CHINA Session Chair: Ling Su, Senior Vice President and Head of Development Greater China, Novartis Pharmaceuticals Corporation, China Over the past few years, multinational pharmaceutical companies are increasingly implementing the strategy of global simultaneous drug development including China. At the same time, the globalisation of drug development activities has significantly facilitated the growth of R&D services in China. In this session, speakers will discuss the recent evolution of drug innovation, regulation, and R&D activities in China under this emerging environment. Regulatory Update Speaker invited Preclinical Development Kewen Jin, General Manager, Charles River Laboratories Great China Preclinical Services, China Clinical Development Speaker invited 11:00-12:30 Session 1506 EASTERN EUROPE/RUSSIA Session Chair: Urszula Scieszko-Fic, Regulatory Affairs Director, Temapharm Sp. z. o.o., Poland Session under development In this session, you will hear a detailed review of the past year at PMDA as well as an overview of initiatives, milestones and current trends for the next year. You will hear directly from senior-level PMDA representatives on issues that may significantly affect your organisation’s regulatory operations
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