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X-WR-CALDESC:Veranstaltungen für AGAH
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DTSTART:20050327T010000
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DTSTART;VALUE=DATE:20050317
DTEND;VALUE=DATE:20050319
DTSTAMP:20260929T020230
CREATED:20190315T005908Z
LAST-MODIFIED:20190612T072121Z
UID:1333-1111017600-1111190399@dev.agah.eu
SUMMARY:14th AGAH Annual Meeting 2005
DESCRIPTION:Early drug development – scientific and regulatory challenges\n\n\n\n	Announcement \n\n\n\nMarch 17 – 18\, 2005\, Strasbourg\nThis first joint meeting of AGAH – The German Association for Applied Human Pharmacology – and Club Phase I – the French Association of Early Human Drug Development – focused on the scientific and regulatory challenges of early drug development. \nIt addressed technical\, safety and regulatory issues impacting on global clinical development plans. In combining the congress concepts of the two sister organizations this meeting offered a wide array of both plenary lectures and workshops suitable both for newcomers and more experienced members of the scientific community. \n \n \n\n\n\n\n\n\n\n	Introduction \nA rbe it s gem e in s ch aft für an ge w an dte\nHu m an ph arm ak ol o gi e ( AG A H) e . \nThis first joint meeting of AGAH—the German\nAssociation for Applied Human Pharmacology - and the\nClub Phase I - the French Association of Early Human\nDrug Development - focuses on the scientific and regulatory challenges of early drug development. It will\naddress technical\, safety and regulatory issues impacting\non global clinical development plans. In combining the\ncongress concepts of the two sister organizations this\nmeeting offers a wide array of both plenary lectures and\nworkshops suitable both for newcomers and more experienced members of the scientific community. Strasbourg\, the venue for this international congress was\nchosen as a European Capital and for its role as a bridge\nbetween France and Germany and\, obv iously\, for the\nmany attractions the region has to offer. \n\n\n\n\n	Day 1\, Thursday\, 17 March 2005  \n\n08.30  \nRegistration and c offee \n\n09.15  \nOpening remarks \nG. Mikus (AGAH) and Y. Donazzolo (Club Phase 1) \n\nSession I \n Current approaches in human pharmacology \n\nChair \n H Fuder and H Caplain \n\nPlenary lectures \n\n09.30  \nIs Phase I useful? \nW. Seifert\, Berlin \n\n09.55  \nHealthy volunteers or patients as target population in Phase I trials \nH. Fuder\, Berlin \n\n10.20  \nWhen to stop dose escalation: MTD or MLD or ...? \nH. Caplain\, Paris \n\n10.45  \nCoffee break \n\nParallel workshops \n\nDesign aspects of Phase I studies and recruitment bias during early development\nM. Buise\, Brussels ; B. Boutouyrie\, Basel\, G. Nemitz\, Biberach\nWomen in Phase I studies\nC. Klipping\, Nijmegen ; D. HegerMahn\, Berlin ; K. Breithaupt-Grögler\, Frankfurt\nPediatric clinical trials\nE. Autret-Leca\, Paris\nSpecial populations\nB. Schug\, Oberursel\nNew drugs in oncology\nJL. Pinquier\, Paris ; P. Squiban\, Strasbourg \n\n\n12.30— 14.00 \nLunch break \n\nSession II  \nImplications of the new EU-directive on clinical trials  \n\nChair \n Y Donazzolo and R Schulz \n\nPlenary lectures\nExperience reports from the first year of working wit hin t he new regulatory environment:  \n\n14.00  \nFrance \n A. Patat\, Paris \n\n14.15  \nGermany \n R. Frey\, Wuppertal \n\n14.30  \nUnited Kingdom \n S. Warrington\, London \n\n14.45  \nThe Netherlands \nJ. van Gerven\, Leiden \n\n15.00 \nCentral Europe \n C. Reh\, Berlin \n\n15.15 \nComparison between European countries \n A. Patat\, Paris \n\n15.45  \nCoffee break \n\n16.00 - 17.15 \nRound table discussion\nChair: I Klingmann\, Brussels\nWhat is going well within the EU directive?\nNecessary improvements?\nICH guideline for all?\nWhat do clinical researchers require from the EU directive in 2010?\nC. Belorgey\, Paris ; G. Schwarz\, Bonn ; F. Chapuis\, Lyon ; T. Sudhop\, Bonn ; B. Lehmann\, Brussels ; A. Patat\, Paris ; R. Frey\, Wuppertal ; S. Warrington\, London ; J. van Gerven\, Leiden ; C. Reh\, Berlin \n\n\n\n\n	Day 2\, Friday\, 18 March 2005  \nSession III  \nSafety issues in Phase I trials  \n\nChair \n M Sibille\, J van Gerven \n\n08.30  \nIs Phase I safe? \n M. Sibille\, Lyon \n\n09.00  \nFirst dose and dose escalation \nB. Reigner\, Basel \n\n09.30  \nAllometric scaling \nG. Sanderink\, Paris \n\n10.00—10.30 \nCoffee break \n\n10.30 -12.00 \nParallel workshops: \n\n QTc: Predictability\, science\, regulations\nM. Drici\, Nice ; P. Maisonblanche\, Paris\nPredictability of toxicity\, population\, CNS markers\nJ. van Gerven\, Leiden\nBiotech products: Predictability from preclinical data\nM. Zühlsdorf\, Wuppertal ; G. Lemm\, Leverkusen ; P. Guillet\, Paris\nBridging the tolerability gap between healthy volunteers and patients\nH. Allain\, Rennes ; U. Feifel\, Biberach \nSafety guidelines\nD. Sallieres\, Paris\n\n\n12.00—13.30  \nLunch break \n\nSession IV  \nNew tools in early drug development  \n\nChair \n G Mikus and P Rosenzweig \n\n13.30  \nWhen and how do PK/PD modelling and simulations make sense in early development? \nE. Fuseau\, Aix-en-Provence \n\n14.00  \nInformed consent process in pharmacogenomic studies (Germany\, France\, international views) \nKL. Rost\, Berlin \n\n14.30  \nImaging in early drug development \nD. Brooks\, London \n\n15.15  \nUsing proteomics to follow response to novel therapies \nB. Acres\, Strasbourg \n\n15.45  \nClosing remarks \nJL. Imbs\, Strasbourg \n\n\n\n\n	Congress Information \nDate:\n17 and 18 March 2005 \nConference venue:\nHotel Sofitel\n4 Place Saint-Pierre-le-Jeune\n67000 Strasbourg\nFrance\nTelephone +33 (0)388 15 49 00\nFax +33 (0)388 15 49 99 \nRegistration:\nCongress Office\nc/o Optimed\n1\, rue des Essarts\n38610 Gières\nFrance\nTelephone +33 (0)4 38 37 27 58\nFax +33 (0)4 38 37 27 41\nE-mail meeting2005@clubphase1.org\nHomepage www.clubphase1.org\nwww.agah-web.de \nFees:\n225 € Members of AGAH and CP1\, and full-time academics\n250 € Non members\n-25 € Additional discount for registrations received before 16 December 2004\nFees include admission to all sessions\, lunch and coffee breaks \n  \nAccommodation:\nA number of rooms at special discounted rates are available at the Venue and other Accor Group Hotels within easy walking distance. See the homepage for details. Please make your own reservations early. \n  \n\n\n\n\n	Presentations of the Annual Meeting 2007 \n\nSession I: Why do we need Phase I studies?\n\n\nW. Seifert\, Berlin\n\nIs-Phase-I-useful-Seifert_01\nIs Phase I useful? \n\nH. Fuder\, Mulhouse\nHealthy-volunteers-or-patients-Fuder_01\nHealthy volunteers or patients as target population in Phase I trials? \n\nH. Caplain\, Paris\nStop-dose-escalation-Caplain_01\nWhen to stop dose escalation – MTD or MLD or ? \n\nSession II: Implications of the new EU-Directive on clinical trials\n\nA. Patat\, Paris\nEU-Directive-France-Patat\nFrance \n\nR. Frey\, Wuppertal\nEU-Directive-Germany-Frey\nGermany \n\nS. Warrington\, London\nEU-Directive-UK-Warrington_01\nUnited Kingdom \n\nJ. van Gerven\, Leiden\nEU-Directive-Netherlands-van-Gerven\nThe Netherlands \n\nC. Reh\, Berlin\nEU-Directive-Central-Europe-Reh\nCentral Europe \n\nA. Patat\, Paris\nComparisons-between-European-countries-Patat\nComparison between European countries \n\nSession III: Safety issues in Phase I studies\n\nM. Sibille\, Lyon\nIs-Phase-I-safe-Sibille_01\nIs Phase I safe? \n\nB. Reigner\, Basel\nFirst-dose-and-escalation-Reigner_01\nFirst dose and dose escalation \n\n\n\n\nG. Sanderink\, Paris\n\n\nAllometric scaling\nNo presentation available \n\n\n\n\nSession IV: New tools in early drug development\n\n\nE. Fuseau\, Aix-en-Provence\nPKPD-in-early-development-Fuseau_01\nWhen and how does PK/PD modelling and simulation make sense in early development \n\n\nK.L. Rost\, Berlin\n\n\nInformed consent process in pharmacogenomic studies (Germany\, France\, international view)\nNo presentation available \n\n\nR. Myers\, London\nPET-scan-Myers_01\nImaging in early drug development \n\n\nB. Acres\, Strasbourg\n\n\nNew compounds derived from research on proteomics\nNo presentation available \n\n\nWorkshops\n\nH. Allain\, Rennes\nPharmacogenomics-and-drug-safety-Allain_01\nPharmacogenomics and drug safety \n\nP. Maisonblanche\, Paris\nQTc-Maisonblanche_01\nQTc: Predictability\, Science\, Regulation \n\nM. Buyse\, Bruxelles\nPhase-I-in-oncology-Buyse_01\nPhase I in Oncology
URL:https://dev.agah.eu/event/annual-meeting-2005/
LOCATION:Annual Meeting 2005\, Strasbourg\, Frankreich
CATEGORIES:Jahrestreffen
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