BEGIN:VCALENDAR
VERSION:2.0
PRODID:-//AGAH - ECPv5.16.4//NONSGML v1.0//EN
CALSCALE:GREGORIAN
METHOD:PUBLISH
X-WR-CALNAME:AGAH
X-ORIGINAL-URL:https://dev.agah.eu
X-WR-CALDESC:Veranstaltungen für AGAH
BEGIN:VTIMEZONE
TZID:Europe/Berlin
BEGIN:DAYLIGHT
TZOFFSETFROM:+0100
TZOFFSETTO:+0200
TZNAME:CEST
DTSTART:20090329T010000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:+0200
TZOFFSETTO:+0100
TZNAME:CET
DTSTART:20091025T010000
END:STANDARD
END:VTIMEZONE
BEGIN:VEVENT
DTSTART;VALUE=DATE:20090428
DTEND;VALUE=DATE:20090501
DTSTAMP:20260929T021544
CREATED:20190310T162246Z
LAST-MODIFIED:20190612T070136Z
UID:1178-1240876800-1241135999@dev.agah.eu
SUMMARY:3rd Joint Annual Meeting and 18th AGAH Annual Meeting 2009
DESCRIPTION:Managing Challenges in Early Drug Development:  \nBiologicals and Small Molecules \n\n\n\n	Announcement \n\n\nApril 28 – 29\, 2009\, Lyon (Hotel Espace Tete d’or)\, France \nBiologics and small molecules are a challenging experience and expectations as to their potential are high. However\, the first administration of a new compound to man is a particularly critical moment in drug development\, pre-clinical information is limited and not necessarily transferable to humans. New molecules with not yet fully understood pharmacological action can yield unpredictable outcomes of otherwise well designed trials. \nThis meeting addressed how sponsors\, investigators\, regulatory authorities and ethics committees might adapt to these new challenges. It was also the third Joint Meeting of AGAH and Club Phase 1 and we were delighted to welcome also many of our colleagues from Belgium and the UK. \n\n\n\n\n\n\n	Introduction \n\n\nMANAGING CHALLENGES IN EARLY\nDRUG DEVELOPMENT\nBiologics and small molecules are a challenging experience and expectations as to their potential are high.\nHowever\, the first administration of a new compound to\nman is a particularly critical moment in drug development\, pre-clinical information is limited and not necessarily transferable to humans. New molecules with not\nyet fully understood pharmacological action can yield\nunpredictable outcomes of otherwise well designed\ntrials.\nThis meeting will address how sponsors\, investigators\,\nregulatory authorities and ethics committees are adapting to these new challenges. It is already the third Joint\nMeeting of AGAH and Club Phase 1 and we are delighted to also welcome our colleagues from Belgium\nand the UK. \n\n\n\n\n\n\n	Day 1\, Tuesday\, April 28\, 2009  \n\n08:30  \nRegistration \n\n09:00  \nOpening Remarks\nA. Patat\, Rennes; M. Sibille\, Lyon;\nT. Thomsen\, Andernach \n\nSession 1:  \nNew biological entities and vaccines \n\nChair \n H. Caplain\, Paris; J.-F. Nicolas\, Lyon \n\n09:15 \nNew targets – new vaccines\nJ.-F. Nicolas\, Lyon\nEarly development plan for a vaccine\nR. Forrat\, Lyon\nDevelopment of new biological entities\nJ.-Y. Bonnefoy\, Strasbourg \n\n10:45 \nCoffee Break \n\n11:15  \nParallel w orkshops\n1) Update on the design of studies of drug-drug interaction with special focus on transporters\nD. Chassard\, Paris; J.-M. Scherrmann\, Paris\n2) Human pharmacology’s contribution to the preparation of paediatric development plans\nI. Klingmann\, Brussels; W. Seifert\, Berlin\n3) Critical appraisal of studies with elderly in early development\nC. Reh\, Berlin\n4) Determination of antibodies following administration of small proteins\nI. Paty\, Paris; F. Bérard\, Lyon; P. Cortez\, Montpellier\n5) What to expect from Holter ECGs in early development?\nP. Voiriot\, Nancy\n6) AHPPI workshop:\nTranslational medicine – dream or nightmare?\nP. Dewland\, Llanyre; T.Mant\, London \n\n12:45 \nLunch Break \n\nSession 2: \n Current European experience with trial approval in early development  \n\nChair \n I. Klingmann\, Brussels; A. Patat\, Rennes \n\n14:00  \nAFSAPPS: Data on timelines\, missing aspects in dossiers\, reasons for delays\, questions to applicants\, how to improve the process\nC. Belorgey\, Paris\nBfArM / PEI: Data on timelines\, missing aspects in dossiers\, reasons for delays\, questions to applicants\, how to improve the process\nT. Sudhop\, Bonn\nBelgium: Data on timelines\, missing aspects in dossiers\, reasons for delays\, questions to applicants\, how to improve the process\nW. Janssens\, Brussels\nUK: Data on timelines\, missing aspects in dossiers\, reasons for delays\, questions to applicants\, how to improve the process\nJ. Ward\, London  \n  \n\n15:30  \nCoffee Break \n\nDifferences in responses from Ethics Committees to clinical trial applications in France\nF. Chapuis\, Lyon\nDifferences in responses from Ethics Committees to clinical trial applications in the UK\nM. Bone\, Newcastle\nDifferences in responses from Ethics Committees to clinical trial applications in the Netherlands\nR. A. de Zeeuw\, Assen\nApplicants perspective on data from the approval process between 2004 and 2008\nT. Ruppert\, Berlin  \n  \n\n17:00  \nRound table discussion on trial approval in early drug development\nAll speakers of the afternoon session Introduction: ICREL results on trial approval\nI. Klingmann\, Brussels  \n  \n\n17:45 \nEnd of Session \n\n19:30  \nConference Dinner \n\n\n\n\n	Day 2\, Wednesday\, April 29\, 2009  \nSession 3 \nManaging the risk of Phase I trials \n\nChair \nY. Donazzolo\,Grenoble; K. BreithauptGrögler\, Frankfurt/M \n\n08:45  \nIdentification and mitigation of risks in first-inhuman clinical trials - pitfalls and challenges of a unified process within a worldwide CRO\nM. Grossmann\, Berlin\nUsefulness of MABEL concepts\nB. Laurijssens\, London\nAccreditation of phase I units in the UK\nJ. Täubel\, London\nAccreditation of phase I units in France\nA. Patat\, Rennes\nAccreditation of phase I units in Germany\nT. Thomsen\, Andernach  \n\n10:30  \nCoffee Break \n\n11:00  \nParallel w orkshops\n7) Monoclonal antibodies in or out of oncology.\nG. Salles\, Lyon; N. Franchimont\, Zug\n8) Society for Pharmaceutical Medicine workshop: MABEL Concept\nD. Jones\, London; B. Laurijssens\, London\n9) Personalized medicine / theragnostics.\nM. Zühlsdorf\, Cologne\n10) Informed consent in pharmacogenomics / individualized medicine – responses from various ethics committees within the EU.\nM. Könen-Bergmann\, Ingelheim\n12) Exploratory trials workshop\nY. Donazzolo\, Grenoble; D. Tremblay\, Paris\n11) BAPU workshop: What is a healthy volunteer?\nD. van der Mijnsbrugge\, Antwerp;\nS. Ramael\, Brussels \n\n12:30  \nLunch Break \n\nSession 4 \nSafety concerns in early development \n\nChair \n I. Paty\, Paris; H. Fuder\, Hamburg \n\n13:30  \nStopping criteria in first-in-man studies\nA. Patat\, Rennes\, M. Sibille\, Lyon\nSerious adverse event registry\nM. Sibille\, Lyon\, C. Hinze\, Rheinau\nLessons learned from thorough QTc studies performed by a pharmaceutical company\nH. Caplain\, Paris\nNew approaches for the assessment of drug abuse liability\nJ.-L. Pinquier\, Paris  \n\n15:45  \nClosing Remarks\nA. Patat\, Rennes \n\n16:00  \nEnd of Meeting \n\n\n\n\n	Fees \n  \nFees \n\n\n\nMembers*\n325 EUR\n\n\nNon-members\n375 EUR\n\n\nDay ticket\n200 EUR\n\n\n\n*) Members of AGAH\, CPI\, AHPPI\, BAPU\, and SPM \nOnline registration and hotel reservation:\nPlease use the link to the Kuoni registration form at www.clubphase1.fr or www.agah-web.de \n\nOnline registration and hotel reservation:\nhttp://www.intercom-dresden.de/agah2010/ \n  \n\n\n\n\n	Downloads \nBélorgey\, Ch.\nFrench experience Ch Belorgey 01.pdf(151 kB) \nCurrent European Experience with trial approval in early development: Afssaps (France) \n\nBone\, M.\nBone Ethics review UK AAHP Lyon 01.pdf(2.1 MB) \nResearch Ethics Review in The UK: Improving the process with a focus on the Integrated Research Application System (IRAS) \n\nChassard\, D.\nPraes. Chassard DDI DC 30MAR09 2 01.pdf(371 kB) \nDrug-Drug interactions. Update on the Study Design \n\nCortez\, P.\nWorkshop AGAH Club Phase I P Cortez version pour edition May2009 01.pdf(1.0 MB) \nImmunogenicity of Biological products \n\nDewland\, P.\nTranslational Nightmare PDewland 01.pdf(226 kB) \nTranslational Medicine \n\nde Zeeuw\, R.\nPresentation Lyon Rokus de Zeeuw 01.pdf(78 kB) \nTrial Approval in Early Drug Development: Current Experiences in The Netherlands \n\nDonazzolo\, Y. & Tremblay\, D.\nExploratory trials DTremblay YDonazzolo 01.pdf(173 kB) \nExploratory clinical trials workshop \n\nJanssens\, W.\nBelgium experience W Janssens.pdf(406 kB) \nTimelines\, missing aspects in dossiers\, reasons for delays\, questions to applicants\, how to improve the process \n\nLaurijssens\, B.\nMABEL BLaurijssens 01.pdf(0.9 MB) \nUsefulness of MABEL concepts \n\nMant\, T.\nTranslational Dream or Nightmare TMant 01.pdf(1.7 MB) \nTranslational Medicine: Dream or Nightmare? \n\nPatat\, A.\nFrance CPU Accreditation APatat 01.pdf(77 kB) \nAccrediation of Phase I Units and protection of the subjects participating in clinical trials in France \n\nPatat\, A.\, Sibille\, M.\, Caplain\, H.\, Donazzolo\, Y.\, Chalon\, S.\nStopping rules APatat MSibille 01.pdf(696 kB) \nStopping rules in First entry into human studies \n\nSalles\, G.\nAnticorps Kc G Salles.pdf(154 kB) \nPhase I studies of MoAbs in Oncology \n\nSibille\, M. & Hinze\, C.\nFrench and German SAE Registers MSibille CHinze 01.pdf(1.3 MB) \nSerious adverse events in Phase I: French and German SAE Registers \n\nTaubel\, J.\nUK CPU Accreditation JTaubel 01.pdf(223 kB) \nManaging the risk of Phase I trials: Accreditation of Phase I Units in the UK \n\nThomsen\, T.\nGermany CPU Accreditation TThomsen 01.pdf(250 kB) \nManaging challenges in early drug development: Biologicals and small molecules \n\nScherrmann\, J.M.\nTransporters in ADE 01.pdf(1.9 MB) \nTransporters in ADE \n\nWard\, M.\nUK experience M Ward 01.pdf(789 kB) \nCurrent UK experience with trial approval in early development
URL:https://dev.agah.eu/event/3rd-joint-annual-meeting-2009/
LOCATION:Annual Meeting 2009\, Lyon\, Frankreich
CATEGORIES:Jahrestreffen
END:VEVENT
END:VCALENDAR