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X-WR-CALDESC:Veranstaltungen für AGAH
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DTSTART:20080330T010000
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DTSTART;VALUE=DATE:20080417
DTEND;VALUE=DATE:20080420
DTSTAMP:20260929T024629
CREATED:20190311T205544Z
LAST-MODIFIED:20190612T080323Z
UID:1185-1208390400-1208649599@dev.agah.eu
SUMMARY:17th AGAH Annual Meeting 2008
DESCRIPTION:Safety and Risk Management in Translational Medicine \n\n\n\n	Announcement \n\n\nApril 17 – 19\, 2008\, Weimar (Germany) \nThe Annual Meeting 2008 focused on discussing techniques\, systems and strategic approaches to improve the safety of study participants\, to minimize their risk of serious adverse reactions and to improve the predictivity of the safety profile of a new compound. Concepts and guidelines for the new regulatory environment for Phase I studies in the EU were presented. Experts from all involved research areas shared their experiences\, discussed their limitations in interpreting the clinical relevance of their studies‘ results and presented their concepts for improving the drug development process. \n\n\n\n\n\n\n	Introduction \n\n\nSAFETY AND RISK MANAGEMENT\nIN TRANSLATIONAL MEDICINE\nDrug development must find a balance between the excitement\nof discovering new treatment options and the protection of\nsubjects participating in clinical trials. Healthy volunteers and staff\nresponsible for their well-being are relying on the adequacy of\nthe procedures applied to minimize risk during the exploratory\nphases. Hence\, the results of pre-clinical pharmacological\nmodels\, toxicological studies and foregoing clinical trials in\nhealthy volunteers and patients are expected to be of predictive\nvalue for the next step. With the increasing number of biologicals\nand compounds with completely new mechanisms of action this\nconcept may no longer be satisfactory\, as has been painfully\nexperienced with the first administration of TGN1412 to healthy\nvolunteers.\nToday’s drug development is subjected to a highly regulated and\nsegmented setting. A closer cooperation between pre-clinical and\nclinical experts is essential to identify and select the appropriate\ninvestigational tools\, to early identify potential safety issues\, and\nto translate the findings of exploratory trials into efficacious and\nsafe new drugs.\nThis conference focuses on finding appropriate techniques and\nstrategic approaches to improve the safety of study participants\,\nto minimize risk\, and to improve the predictive value of the\nsafety profile for a new compound. Concepts and guidelines\nfor the new regulatory environment for Phase I studies in the EU\nwill be presented. Experts from all research areas involved will\nshare their experience\, discuss the limitations of interpreting the\nclinical relevance of their studies‘ results and present concepts for\nimproving the drug development process.\nThe meeting will be held in English. \n\n\n\n\n\n\n	Day 1\, Thursday\, April 17\, 2008  \n\n18:00  \nGet-together \n\n19:00 \nAGAH General Assembly \n\n\n\n\n	Day 2\, Friday\, April 18\, 2008  \n08:30 \nRegistration \n\n09:00  \nOpening remarks (Torben Thomsen) \n\nSession I  \nThe Predictive Relevance of Preclinical Safety Information \n\nChair \n Hermann Fuder\, Michael Zühlsdorf \n\n09:10  \nFundamental international regulatory requirements for human trials \nEckhard von Keutz\, Wuppertal \n\n09:40  \nImplications of pharmacological models for risk assessment \nUlrich Kalinke\, Langen \n\n10:10  \nCan toxicogenomics predict safety? \nFrank Staedtler\, Basel \n\n10:40  \nRelevance of toxicological findings for drug safety in humans \nKlaus Olejniczak\, Bonn \n\n11:10 \nCoffee Break \n\n11:40  \nParallel workshops:\n• Studies with radiolabelled drugs in Germany\n(Gerhard Scheuch\, Gauting)\n• Literature search and how to improve knowledge\nmanagement (Oliver Renn\, Biberach)\n• Comparison of International First-in-Man\nGuidelines (Ingrid Klingmann\, Brussels) \n\n13:10  \nLunch \n\nSession II \n The Predictive Relevance of Human Pharmacology Trials\nfor Drug Safety \n\nChair \nGerd Mikus\, Wolfgang Timmer \n\n14:30  \nRationale for determining the MTD – which findings are really important? \nJoachim Gerloff\, Würzburg \n\n15:00 \nRelevance of Phase I SAEs\, SUSARs and important medical\nevents for patient safety \nMichel Sibille\, Lyon \n\n15:30 \nHow predictive is QTc prolongation really? \nWilhelm Haverkamp\, Berlin \n\n16:00 \nCoffee Break \n  \n\nSession III  \nThe expedited CTA – a suitable approach for Europe? \n\nChair \nUlrich Feifel\, Thomas Sudhop \n\n16:30 \nA Panel and Open Forum Discussion\n(T. Reum\, Bonn; E. Stahl\, Bonn; S. Hockertz\, Seelze;\nW. Beier\, Munich; E. von Keutz\, Wuppertal)  \n\n19:30 \nConference Dinner (Alte Remise\, Tiefurt) \n\n\n\n\n	Day 3\, Saturday\, April 19\, 2008 \nSession IV  \nIntegrated Preclinical and Clinical Safety\nAssessment and Applications \n\nChair \nKerstin Breithaupt\, Torben Thomsen \n\n08:30  \nAssessment of drug-relationship of AEs in Phase I \nMatthias Großmann\, Berlin \n\n09:00  \nRelevance of pre-clinical findings for the interpretation of Adverse Events \nTimothy Mant\, London \n\n09:30  \nSafety signals in Phase I as triggers for go/no-go decision in further development \nGeorg Wensing\, Wuppertal \n\n10:00  \nCoffee Break \n\n10:30 \nParallel workshops: \n\nMinimising risk by optimising clinical trial design and performance\nWolfgang Timmer\, Mannheim\nExperience with and options for microdosing studies\nBerend Oosterhuis\, Zuidlaren; Andreas Kovar\, Darmstadt\nPractical aspects of clinical trials with challenge agents\nHermann Fuder\, Hamburg\nBurn-out and work-life balance (in German)\nWolfgang Seifert\, Berlin; Katharina Erb-Zohar\, Hanau\n\n\n12:00 \nCoffee Break \n\nSession V  \nHuman Pharmacology for Biologicals \n\nChair \n Christian Hinze\, Ingrid Klingmann \n\n12:10 \nRelationship between CMC and toxicology in the development of biologicals\nStefan W. Hockertz\, Seelze \n  \n\n12:40  \nClinical development programmes for biosimilars \nHildegard Sourgens\, Munich \n\n13:10  \nSpecific challenges in human pharmacology trials with biologicals \nWolfgang Greb\, Neuss \n\n13:40 \nClosing Remarks \nGerd Mikus \n  \n\n13:45  \nFarewell lunch \n\n\n\n\n	Congress Information \nDate:\nApril 18 – 19\, 2008 \nConference venue:\nLeonardo Hotel Weimar\nBelvederer Allee 25\nD-99425 Weimar\, Germany\nTel.: +49 (0) 3643 - 722 - 0\nFax: +49 (0) 3643 - 722 - 2320\nWeb: www.leonardo-hotels.com \nRegistration:\nINTERCOM Dresden GmbH\nAntje Blömeke\nZellescher Weg 3\nD-01069 Dresden\, Germany\nTel.: +49 (0) 351- 4633 - 3060\nFax: +49 (0) 351- 4633 - 7049\nE-mail: abloemeke@intercom.de\nWeb: www.agah-web.de  \nFees \n\n\n\nMembers\n325 EUR\n\n\nNon-members\n375 EUR\n\n\nJunior Scientist*\n200 EUR\n\n\nIndustry Exposition Staff\n275 EUR\n\n\nDay ticket\n200 EUR\n\n\n\n* under the age of 30 years \nFees include admission to all sessions\, lunches and\ncoffee breaks. \nAccommodation:\nA number of rooms at special discounted rates are\nblocked and available via INTERCOM Dresden GmbH. \nAGAH e.V.\nPO Box 540116\nD-01311 Dresden\, Germany\nTel.: +49 (0) 351 - 410 99 71\nFax: +49 (0) 351 - 410 99 72\nE-mail: sekretariat@agah-web.de\nWeb: www.agah-web.de  \n\n\n\n\n	Program Commitee  \nIngrid Klingmann\, Kerstin Breithaupt-Grögler\, Ulrich Feifel\,\nHermann Fuder\, Christian Hinze\, Wolfgang Timmer \n\n\n\n\n	Downloads \nH. Fuder\nAGAH-WS ChallengeAgentsHFuder190408pdf.pdf(537 kB) \nAGAH-Workshop “Practical aspects of clinical trials with challenge agents” \n\nW. Greb\nAGAH-WS_ChallengeAgentsHFuder190408pdf \nSpecific Challenges in Human Pharmacology Trials with Biologicals \n\n\nT. Mant\n\nAGAH__Weimar_-_Germany__presentation__version_for_website_ \nRelevance of pre-clinical findings for the interpretation of Adverse Events \n\nB. Oosterhuis\n1st_presentation_Oosterhuis_AGAH \nAGAH Workshop „Experience with and options for microdosing studies“ \n2nd_presentation_Oosterhuis_AGAH \nAGAH Workshop „Experience with and options for microdosing studies“ \n\nW. Seifert and K. Erb-Zohar\nBurnout_Artikel_AGAH080528_1 \nAGAH-Workshop „Burn-out and work-life balance“ \n\nH. Sourgens\nVortragWeimar2008-p1-10_01 \nClinical Development Programmes for Biosimilars und Literatur \nRetacrit__INN_-_epoetin_zeta_01 \nCanada-Consultation_on_Draft_Guidance_for_Sponsors__Information_and_Submission_Requirements_for_Subsequent_Entry_Biologics__SEBs_ \nBurnout_Artikel_AGAH080528_1 \n\nW. Timmer\nAGAH_Workshop \nAGAH-Workshop „Minimising risk by optimising clinical trial design and performance“
URL:https://dev.agah.eu/event/agah-annual-meeting-2008/
LOCATION:Annual Meeting 2008\, Weimar\, Deutschland
CATEGORIES:Jahrestreffen
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