EuroMEEting - Genetic Alliance UK

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34 THEME 10 | THEME 11 This is the advance programme. New speakers and sessions will be added. Visit www.diahome.org for the most recent additions to the programme. The Role of the Pharmacopoeia in the New Quality Paradigm Susanne Keitel, Director, European Directorate for the Quality of Medicines and Healthcare (EDQM), EU Wednesday, 30 March 2011 09:00-10:30 Session 1005 GLOBALISATION OF MEDICINE (1): IMPACT ON QUALITY Session Chair: Jacques Morenas, Deputy Director, AFSSAPS, France Stephan Roenninger, Global Quality Manager, F. Hoffmann-La Roche AG, Switzerland Session under development 11:00-12:30 Session 1006 GLOBALISATION OF MEDICINE (2): COUNTERFEITING ASPECTS Session Chair: Thierry Bourquin, Vice President, Global Quality, Sanofi-Winthrop Industrie, France Session under development 14:00-15:30 Session 1007 PAEDIATRIC FORMULATIONS Session Chair: Diana van Riet, Coordinator, Regulatory Affairs, National Institute for Public Health and the Environment, The Netherlands This session is dedicated to the coming EU guideline on the pharmaceutical development of medicines for paediatric use. The session will provide an indepth review of the current approaches towards fundamental aspects as the selection of the dosage form, the safety of excipients and patient acceptance, both from a European, WHO and US perspective. It will also update the audience on the latest achievements towards these aspects as achieved by EUPFI, a consortium of EU industry and academia. The European Quality Guideline on Paediatric Formulations Diana van Riet, Coordinator, Regulatory Affairs, National Institute for Public Health and the Environment, The Netherlands A Global Perspective on the Pharmaceutical Development of Paediatric Medicines Emma Du Four, Director, Regulatory Policy & Intelligence, Abbott Laboratories, UK Fostering Knowledge on Paediatric Formulation Development: An update from EUPFI Speaker invited 16:00-17:30 Session 1008 WHAT’S NEW IN QUALITY? (WITH QUESTIONS FROM THE AUDIENCE) Session Chair: Michael J. James, Head of CMC Regulatory Advocacy and Intelligence, Global Regulatory Affairs, GlaxoSmithKline, UK This session will provide an update of the key quality initiatives in EU, and will reflect the higher priority topics and activities of both the CHMP Quality Working Party and the EFPIA Technical Development Operations Committee. The following topics are foreseen, but may be revised due to future developments: • process validation/continuous verification • real time release testing • quality of investigational medicinal products • genotoxic Impurities • impact of implementing ICH Q8, Q9 and Q10 on existing guidelines e.g. specifications • innovative technologies • topics to be proposed by participants. This will be a joint presentation, providing both an industry and EU regulatory agency perspective. It is envisaged that this will be an interactive session, and audience participation will be actively encouraged. Additional topics from the delegates can be proposed prior to the session. EU Regulator’s Point of View Jean-Louis Robert, Head, Department of Medicines Control Laboratory, National Health Laboratory, Luxembourg Industry Point of View Michael J. James, Head of CMC Regulatory Advocacy and Intelligence, Global Regulatory Affairs, GlaxoSmithKline, UK Theme 11 | The Drug/Device Boundary: Is it about to disappear? Michael Hotze, Director, Head of Clinical Research, Institut Straumann AG, Switzerland Shayesteh Fuerst-Ladani, Director, SFL Regulatory Affairs and Scientific Communication Ltd., Switzerland The European regulatory requirements for marketing medical devices are fundamentally different from those for medicinal products. In Europe, the new approach underpins the medical devices requirements, meaning the manufacturer takes full responsibility for bringing medtech products to market. This is in contrast with the medicinal product regulations, where the competent authority takes responsibility for approving, and thus allowing, a medicinal product to be marketed. In areas where medicinal products and medical devices are used in combination, the respective regulations of both have already been adapted to address these products. In addition, more lately, the product documentation requirements for medical devices has been increased: for example, the revision of the Medical Device Directive (MDD), which came into force on March 21, 2010, demands more from manufacturers in terms of both the quality and quantity of clinical data. In this track, an overview of the medical device regulations will be given and differences between these and the pharma requirements highlighted. It will also focus on particular topics in the medical device area. Additional sessions will then address the special situations that arise with medicinal product and medical device combination products, and in vitro diagnostics.
THEME 11 35 This is the advance programme. New speakers and sessions will be added. Visit www.diahome.org for the most recent additions to the programme. Tuesday, 29 March 2011 09:00-10:30 Session 1101 KEYNOTE INTRODUCTORY SPEECHES SETTING THE SCENE Session Chair: Shayesteh Fuerst-Ladani, Director, SFL Regulatory Affairs and Scientific Communication, Switzerland In this session keynote speakers from the European Commission, and the device and drug industries will share their views on the pros and cons of the current European legislation for medical devices and drugs. An update on the ongoing recast of the Medical Device Directives will be provided, and the issue of whether changes are needed to the drug and device laws will be discussed. To What Extent does DG Sanco Anticipate any Elements of Convergence between Drug and Device Regulations in future, and its Reasoning? European Commission speaker invited The Medical Device Industry View on Drug and Device Regulations Converging Toni K. Jørgensen, Senior Vice President Corporate Regulatory Affairs, Institut Straumann AG, Switzerland The Pharma Industry View on Drug and Device Regulations Converging Detlef Niese, Head Development, External Affairs, Novartis Pharma AG, Switzerland 11:00-12:30 Session 1102 BORDERLINE PRODUCTS AND IMPACT ON DEVELOPMENT Session Chair: Geneviève Michaux, Of Counsel, Covington & Burling, Belgium Borderline becomes Border Area Erik Vollebregt, Attorney, Greenberg Traurig, The Netherlands Medicine – Medical Device Borderline Situations David Van Passel, Senior Legal Counsel, Johnson and Johnson, The Netherlands Medicine or Medical Device: What legal consequences? Heike Wachenhausen, Head Legal and Regulatory Affairs, Novartis Pharma AG, Switzerland 14:00-15:30 Session 1103 REGULATORY FRAMEWORK FOR COMBINATION PRODUCTS Session Chair: Michael Hotze, Director, Head of Clinical Research, Institut Straumann AG, Switzerland In this session speakers from industry, a Notified Body and an independent expert will give an overview of the legal framework and the consultation process of the regulatory pathways for registration of drug-device combination products in the US and Europe. In a case study it will be presented how a combination product has been registered globally. Overview of Legal Framework for Combination Products in the EU and the US Shayesteh Fuerst-Ladani, Director, SFL Regulatory Affairs and Scientific Communication, Switzerland Consultation Process for Combination Products Gert Bos, Head of Regulatory and Clinical Affairs, BSI, UK Case Study about Global Regulatory Pathway for Registration of a Combination Product Erika Johnson-Froneberg, Senior Manager Global Regulatory Affairs, Baxter BioScience, Austria 16:00-17:30 Session 0104/1104 IN VITRO DIAGNOSTIC (JOINT WITH THEME 1) Session Chair: Mark Hope, Head of Program Management, F. Hoffmann-La Roche AG, Switzerland Case Study: Development of an IVD Stephen Little, Vice President, Personalised Healthcare, Qiagen, UK Point of Care Testing in Clinical Trials Michael Wickham, Managing Director, Woodley Equipment Company Ltd., UK Case Study of Regulatory Process of Registration of In Vitro Diagnostic with a Medicinal Product Mark Hope, Head of Program Management, F. Hoffmann-La Roche AG, Switzerland Wednesday, 30 March 2011 09:00-10:30 Session 1105 POINTS TO CONSIDER IN CLINICAL DEVELOPMENT OF COMBINATION PRODUCTS Session Chair: Sabina Hoekstra-van den Bosch, Senior Advisor, Department of Pharmaceutical Affairs and Medical Technology, Ministry of Health, Welfare and Sport, The Netherlands Clinical Design of a Combination Product Edith Hantak, Director Clinical Development, Baxter Innovations GmbH, Austria Effective Planning of Medical Device vs. Drug Clinical Studies: Key Considerations Molly Blake-Michaels, Director, Clinical Services, ClearTrial, LLC, USA Insights from FDA International GCP Inspections of Device and Device-Drug Combination Products: Case studies for building high-quality data Lester Jao Lacorte, FDA Medical Officer, Commissioner’s Fellow, FDA, USA 11:00-12:30 Session 1106 THE DEVELOPMENT OF MEDICAL DEVICES Session Chair: Amanda Maxwell, Manager, SFL Regulatory Affairs Consulting, UK This session will have an introduction to the work of the Global Harmonisation Task Force and the International Conference on Harmonisation, an overview of the device development process and a summary of how to combine device vigilance and pharmacovigilance responsibilities within one company. Introduction to the Global Harmonisation Task Force and Comparison with the International Conference on Harmonisation (ICH) Amanda Maxwell, Manager, SFL Regulatory Affairs Consulting, UK The Development Process for Medical Devices Neil R. Armstrong, CEO, MeddiQuest Limited, UK
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