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X-WR-CALDESC:Veranstaltungen für AGAH
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DTSTART;VALUE=DATE:20110331
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SUMMARY:20th AGAH Annual Meeting 2011
DESCRIPTION:Joint Conference of European Human Pharmacological Societies and 20th Anniversary of AGAH \nExploratory Development of Modern Therapies – Biologicals\, Advanced Therapies and Drug-Device Combinations \n\n\n\n	Announcement \n\n\nHuman Pharmacology is still a relatively young discipline. Only in the 1980ies clinical pharmacologists performing Phase I studies founded dedicated scientific associations to exchange experience\, to foster systematic research and to harmonise quality standards. Since then great progress has been made in early drug development of small molecules for many different indications. Human pharmacology today is crucial for early go/no-go decisions. The growing number of biologicals\, new advanced therapies and innovative modes of drug application like drug/device combinations or nano particles call for new scientific tools. Human pharmacologists have to adapt to completely new mechanisms of action\, pharmacological characteristics\, models\, methodologies and techniques in Phase I/II clinical trials. \nThe best way to compile the current level of knowledge and to exchange the sparse experience on new methodologies is international collaboration. The German AGAH e.V\, the French Club Phase I\, the Belgian BAPU and the British AHPPI decided to join forces and have the great pleasure to invite you to their 1st joint conference. This meeting will update you on new approaches in exploratory development of modern therapies and provides ample opportunity to discuss ideas\, strategies\, methods\, technologies and experience with the early development of biologicals\, advanced therapies and drug-device combinations in 2 days of plenary sessions and workshops. \nCelebrating its 20th anniversary\, AGAH is proud to welcome three sister associations to in Berlin\, where it was founded in 1991. We are most happy to celebrate the development and continuous growth of AGAH\, providing “home” for the majority of human pharmacologists working in pharma companies\, CROs and academic units in Germany. \n \n\n\n\n\n\n\n	Introduction \n\n\n  \n\n\nHuman Pharmacology is still a relatively young discipline. Only in the 1980s clinical pharmacologists performing Phase I studies founded dedicated scientificassociations to exchange experience\, to foster systematic research and to harmonise quality standards. Sincethen great progress has been made in early drug development of small molecules for many different indica- tions. Human pharmacology today is crucial for earlygo/no-go decisions. The growing number of biologicals\,new advanced therapies and innovative modes of drugapplication like drug/device combinations or nanoparticles call for new scientific tools. Human pharmacologists have to adapt to completely new mechanisms ofaction\, pharmacological characteristics\, models\, methodologies and techniques in Phase I/II clinical trials.The best way to compile the current level of knowledgeand to exchange the sparse experience on new methodologies is international collaboration. The GermanAGAH e.V\, the French Club Phase I\, the Belgian BAPUand the British AHPPI decided to join forces and havethe great pleasure to invite you to their 1st joint conference. This meeting will update you on new approachesin exploratory development of modern therapies andprovides ample opportunity to discuss ideas\, strategies\,methods\, technologies and experience with the earlydevelopment of biologicals\, advanced therapies anddrug-device combinations in 2 days of plenary sessionsand workshops.Celebrating its 20th anniversary\, AGAH is proud towelcome three sister associations to Berlin\, where itwas founded in 1991. We are happy to celebrate thedevelopment and continuous growth of AGAH\, providing a “home” for the majority of human pharmacologistsworking in pharmaceutical companies\, CROs and academic units in Germany. \n\n\n\n\n	Day 1\, 31 March 2011  \n\n09:00  \nWelcome and introduction to the first joint meeting of AGAH\, Club Phase I\, BAPU\, AHPPI \n\nSession 1:  \nPRINCIPLES OF EARLY DEVELOPMENTOF BIOLOGICALS \n\nChairs: \nA Patat\, Rennes\, I Klingmann\, Brussels  \n\n9:15 \nImpact of the ICH-M3 guideline on the early development of biologicalsS Plassmann\, Munich \n\n9:45  \nPredictivity of toxicological tests for the early development of biologicalsJ-J Legrand\, Evreux  \n\n10:15  \nFixed dosing versus weight-based dosing in clinical development of biotherapeutic proteinsD Wang\, La Lolla-California  \n\n10:45 \nCoffee Break \n\nSession 2: \n REGULATORY ASPECTS \n\nChairs: \nM Hammond\, Slough\, O Van Schoor\, Antwerp \n\n11:15  \nEMA’s role and responsibilities for the devel- opment of modern therapiesE Flory\, Langen \n\n11:45  \nThe role and responsibilities of a national competent authority in the development of modern therapiesE Godfrey\, London  \n\n12:15 \nSignal detection and risk management in early clinical developmentH Caplain\, Chilly-Mazarin\, P Van der Auwera\, Basle  \n\n12:45  \nLunch Break \n\n14:00  \nPARALLEL WORKSHOPS  \n\nWS 1  \nEarly clinical development of vaccinesM Peeters\, Rixensart\, G Hale\, Abingdon  \n\nWS 2 \nQT-Studies for biologicalsP L’Hostis\, Rennes\, J Täubel\, London  \n\nWS 3  \nStopping rules in exploratory drug developmentA Patat\, Rennes\, Y Donazzolo\, Lyon  \n\nWS 4  \nBiologicals vs. small molecules – What’s the difference?P Lloyd\, Horsham\, G Narayan\, London \n\n15:30 \nCoffee Break \n\nSession 3:  \nEARLY DEVELOPMENT OF DRUGDEVICE COMBINATIONS  \n\nChairs: \n T Thomsen\, Andernach\, U Lorch\, London  \n\n16:00  \nToxicological programme and predictivity of toxicological results for drug-device combinationsA McLean\, London  \n\n16:30 \nRegulatory background for medicinal product / medical device developmentT Sudhop\, Bonn  \n\n17:00  \nExample for an early drug-device development planB Schug\, Oberursel  \n\n17:30  \nEnd of Day 1 \n\n19:30 \nConference Dinner \n\n\n\n\n	Day 2\, 01 April 2011  \nSession 4: \n EARLY DEVELOPMENT OF ADVANCED THERAPIES \n\nChair \n K Breithaupt-Grögler\, Frankfurt\, L Van Bortel\, Gent \n\n9:00 \nGene therapy studiesR Yanez\, Egham \n\n9:30  \nStem cell therapy studiesS Janssens\, Leuven \n\n10:00  \nTissue-engineered productsF Luyten\, Leuven  \n\n10:30  \nCoffee Break \n\n11:00  \nPARALLEL WORKSHOPS  \n\nWS 5  \nPreparation and management of Phase Istudies with stem cell therapyG Tiedemann\, Rostock\, D Sawitzky\, Leipzig  \n\nWS 6  \nModelling and simulation to help MABEL definitionB Laurijssens\, Chambonas\, S Martin\, Sandwich \n\nWS 7 \nEthical dilemmas in modern therapiesI Klingmann\, Brussels\, C Heberlein\, Ebmatingen  \n\nWS 8 \nPractical application of risk assessment andmanagement in early clinical developmentH Caplain\, Chilly-Mazarin\, P Van der Auwera\, Basle  \n\n12:30  \nLunch Break \n\nSession 5:  \nSTRENGTHENING EUROPEAN HUMAN PHARMACOLOGY FOR THE EARLY DEVELOPMENT OF MODERN THERAPIES  \n\nChair \nJ de Hoon\, Leuven\, Y Donazzolo\, Lyon \n\n13:30 \nOpen forum discussion:Need for a uniform European accreditation system for Phase I units?Introduction: U Lorch\, London  \n\n14:15 \nOpen forum discussion:Need for a uniform European registration system for volunteer participation?Introduction: A Peremans\, Antwerp  \n\n15:00  \nOpen forum discussion:Need for SAE-reporting in Phase I studies across countries?Introduction: A Patat\, Rennes \n\n15:45 \nClosing remarksI Klingmann\, Brussels  \n\n16:00  \nEnd of conference \n\n\n\n\n	Information \n  \nVenue\nLangenbeck-Virchow Haus\nLuisenstr. 58/59\, 10117 Berlin\nPhone: +49 (30) 2887 9834 \nDate\nThursday\, 31 March & Friday\, 01 April 2011 \nFees \n\n\n\nMembers of AGAH\, CPI\, AHPPI\, BAPU\n340 EUR\n\n\nNon-members\n400 EUR\n\n\nJunior scientists\n250 EUR\n\n\nDay ticket\n200 EUR\n\n\n\n50\,00 € reduction for early bird registration prior to 15 January 2011 \n\nInquiries\nIntercom Kongresse GmbH\nA. Blömeke\nEppendorfer Baum 39a\n20249 Hamburg\, Germany \nT.: +49 (0)40 4806 1061\nF.: +49 (0)40 4806 1066\nabloemeke@intercom.de \nAGAH: www.agah.info\nCP1: www.clubphase1.fr\nBAPU: www.bapu.be\nAHPPI: www.ahppi.org.uk \n  \n 
URL:https://dev.agah.eu/event/20th-annual-meeting-2011/
LOCATION:Annual Meeting 2011\, Berlin\, Deutschland
CATEGORIES:Jahrestreffen
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