EuroMEEting - Genetic Alliance UK

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32 THEME 9 This is the advance programme. New speakers and sessions will be added. Visit www.diahome.org for the most recent additions to the programme. 14:00-15:30 Session 0903 COMPARING EPRO TECHNOLOGIES: WHAT WORKS? Session Chair: Ingrid Klingmann, Managing Director, Pharmaplex bvba, Belgium Web-Based Assessments: The internet is an emerging modality in Patient Reported Outcomes Brian Tiplady, Senior Clinical Scientist, invivodata, UK A Scientific Comparison of Mobile Data Capture Technologies Being Used in Clinical Trials: Tablet PC, Keyboard, Personal Digital Assistant and Digital Pen Ronald Boldt, Lecturer for Process-Oriented IT-Management at HTW-Berlin / Managing Director, Allpen GmbH, Germany 16:00-17:30 Session 0904 DATA PRIVACY IN THE PHARMA E-WORLD Session Chair: Pierre-Yves Lastic, Senior Director, Data Privacy & Healthcare Interoperability Standards, sanofi-aventis, France In recent years medical research and pharmacovigilance have come under the spotlight of several Privacy and Personal Data Protection Authorities. Spectacular lawcourt decisions have raised public attention and new guidances have been issued by several countries that challenge the way we currently run research and drug safety. In this session, we will be addressing these new challenges and providing possible strategies to face them. Legal Issues Raised by a Research Biobank? Geneviève Michaux, Of Counsel, Covington & Burling, Belgium Wednesday, 30 March 2011 09:00-10:30 Session 0905 PRACTICAL IMPLEMENTATION OF THE CDISC STANDARDS Session Chair: David Iberson-Hurst, CDISC Technical Architect, CDISC, UK Over the past decade CDISC standards became THE reference for clinical research data. However, their implementation can be challenging and this session will propose practical strategies to achieve this goal. Almost There: CDISC end-to-end using one standards set and one format Jozef Aerts, CEO, Xml4pharma, Germany From Protocol Design to Final Reporting: CDISC implementation Richard Young, Area Sales Director, Medidata Solutions Worldwide, UK How to Go Effectively from Data Collection in CDASH to Submission in SDTM: The need for an eCRF library Isabelle de Zegher, Worldwide Senior Director Technology Integration & Data Standards, PAREXEL, Belgium 11:00-12:30 Session 0906 USING TECHNOLOGY TO IMPROVE THE CLINICAL TRIAL PROCESS Session Chair: Liz Love, Product Manager, Perceptive Informatics, UK Producing Quality Data for Clinical Trials: Is full on-site monitoring the only answer? Imane Kermadi, Director, EMEA, Project Coordination Services, Kendle, UK Session under development 14:00-15:30 Session 0707/0907 STATISTICAL COMPUTING: PROGRESS IN COMPUTATIONAL SCIENCE IN CLINICAL TRIALS (JOINT WITH THEME 7) Session Chair: Joachim Vollmar, Executive Consultant, International Clinical Development Consultants LLC, USA One of the most important and unrecognised issues contributing to drug development time and regulatory quality is the ability to acquire, store, analyse, share and report information needed to make the most informed and rapid decisions in pharmaceutical companies, contract research organisations, and international regulatory agencies. This session will review the current state of data standards, and analytical/graphical tool development, as well as user experiences and expectations FDA’s Computational Sciences Initiative: Goals and current state of implementation FDA speaker invited Dynamic and Interactive Tools Michael O’Connell, Director, Life Sciences, TIBCO, USA Graphics Fabrice Bancken, Expert in Quantitative Safety, Switzerland Novartis Pharma AG, 16:00-17:30 Session 0908 CLINICAL TRIAL TECHNOLOGIES AND THE SITE: WHERE NEXT? Session Chair: Maurizio Rainisio, Vice President, Head of Global Biometry, Actelion Pharmaceuticals Ltd., Italy Simplicity (for sites) is the Ultimate Sophistication Keith W. Wenzel, Senior Product Director, eClinical, Perceptive Informatics, USA EDC Achieved: What new challenges did it reveal and what’s next? Simon Brooks, Vice president, Data and Product Integration, Phase Forward, UK
THEME 10 33 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 10 | CMC, Inspection and Assessment, Quality and Counterfeiting Georges France, Vice President Quality Strategy, Global Quality Operation, Pfizer, UK Jean-Louis Robert, Head, Department of Medicines Control Laboratory, National Health Laboratory, Luxembourg This theme will address several different areas concerning the pharmaceutical quality of medicines. The latest developments in the new quality paradigm described by ICH Q8, Q9 and Q10, for drug substance and drug product will be discussed, focusing on the practical aspects and including the role of the pharmacopoeia. Opportunities available to the MA holder from combining good pharmaceutical development and quality risk management with an efficient quality system will be considered (e.g. post-approval change management protocols and the Variations Regulation). The theme will also explore the impact on quality and counterfeiting challenge arising from globalisation of pharmaceutical manufacturing and supply chains, and the recent European legislation concerning the development of paediatric medicines. Finally there will be an opportunity for participants to bring their own topics to the forum for debate. Tuesday, 29 March 2011 09:00-10:30 Session 1001 THE DEVELOPMENT OF PHARMACEUTICAL PRODUCTS IN THE CONTEXT OF THE NEW QUALITY PARADIGM Session Chair: Jean-Louis Robert, Head, Department of Medicines Control Laboratory, National Health Laboratory, Luxembourg This session will cover the latest developments in the New Quality Paradigm impacting the development of drug substances (small molecule and biotech), drug products and how it can facilitate the implementation of new technologies. Molecules of Chemical Origin in the New Paradigm Keith McDonald, Assessment Team Manager, Licensing Division, MHRA, UK Biotech in the New Paradigm Brian Withers, Director, CMC Global Pharmaceutical Regulatory Affairs, Abbott Laboratories, UK Development of New Technology and their Acceptance by Regulators Alastair Coupe, Senior Director, Pharmaceutical Sciences, Pfizer Global R&D, UK 11:00-12:30 Session 1002 NEW PARADIGM, LATEST DEVELOPMENT (2): INTERACTION AND IMPLEMENTATION OF ICH Q8, Q9 AND Q10 Session Chair: Georges France, Vice President Quality Strategy, Global Quality Operation, Pfizer, UK This session will address the achievements of the ICH IWG to achieve consistent, harmonised implementation of Q8, Q9 and Q10, and consider the interaction of these guidelines with the practical implementation of the quality system and new approaches for process validation. An Update on Progress and Achievements of IWG Q8, Q9, Q10 Jean-Louis Robert, Head, Department of Medicines Control Laboratory, National Health Laboratory, Luxembourg Quality Systems Following Q10 Principles: Myth or reality? Nigel Hamilton, Quality Director, Sanofi Aventis, France Process Validation in the New Quality Paradigm Fergus Sweeney, Head of Sector, Compliance and Inspection, European Medicines Agency, EU 14:00-15:30 Session 1003 VARIATION REGULATION: POST-APPROVAL CHANGE MANAGEMENT PROTOCOL Session Chair: Keith Pugh, Expert Pharmaceutical Assessor, MHRA, UK A new variations system was introduced on 1 January 2010 (EC/1234/2008). The accompanying classification guideline introduces the concept of a post-approval change management protocol and addresses how updates in association with agreed protocols will be managed. The protocol is intended to help facilitate the management of post-approval changes to the quality aspects of the dossier, relating to both the active substance and finished product and is not restricted to variations. The session will clarify the principles and procedures related to this new concept as well as reflecting on the potential benefits in terms of simplification and flexibility and any experience to date. Post-Approval Change Management Protocols – a regulatory perspective Keith Pugh, Expert Pharmaceutical Assessor, MHRA, UK Post-Approval Change Management Protocols - Industry perspective for small molecules Speaker invited Post-Approval Change Management Protocols - Industry perspective for biological products Speaker invited 16:00-17:30 Session 1004 IS THERE A NEED FOR A PHARMACOPOEIA IN THE NEW QUALITY PARADIGM? Session Chair: Susanne Keitel, Director, European Directorate for the Quality of Medicines and Healthcare (EDQM), EU The “new quality paradigm” outlined in ICH guidelines Q8, Q9 and Q10 offers additional flexibility to companies, e.g. in defining a design space and their control strategy, based on sound and in-depth development studies. The session will discuss the implications this new paradigm has on the pharmacopoeia – a compilation of legally binding quality standards - and will provide the viewpoint of EU regulators, the innovative and the generic industry and the pharmacopoeia on the future role of the pharmacopoeia in this new environment. A Regulator’s Expectations of the Pharmacopoeia in the New Quality Paradigm Keith McDonald, Assessment Team Manager, Licensing Division, MHRA, UK How can the Pharmacopoeia Fulfil the Innovator’s Needs in the New Quality Paradigm? Graham Cook, Senior Director, Global Quality Operations, Pfizer, UK
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