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DTSTART:20181028T010000
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DTSTART;VALUE=DATE:20180425
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SUMMARY:27th AGAH Annual Meeting 2018
DESCRIPTION:We are most happy to invite you to the AGAH Annual Meeting in April 2018 in Munich. \nThe conference will focus on how to predict as well as on how to prevent adverse drug reactions in early phase drug development. The major target organ systems will be addressed: liver\, kidney\, CNS\, cardiac function. Further sessions will be dedicated to local tolerance and immunotoxicity. \nWe will look into how animal models and in vitro data may help to estimate risk regarding human administration. How can kidney and liver function best be monitored in the settings of early phase trials? What do we need to know to assess potential CNS adverse drug reactions early on? What are the pathophysiological mechanisms leading to potential cardiac toxicity? What are the guidelines on non-clinical local tolerance testing? How to monitor immunotoxicity in novel immunological therapies? There will be ample opportunity to discuss these and additional questions with expert speakers\, regulators and ethic committees members as well as colleagues from pharmaceutical industry\, CRO and academia. \nThe meeting starts with a one-day pre-conference workshop about basic terms and key concepts of pharmacovigilance with a strong focus on early phase drug development. This workshop offers an excellent preparation for the annual meeting for those who are not yet experts in the field. \n\n\n\n	Details \nTarget organs in early medicines development – predictability and prevention of adverse reactions\nWednesday\, 25th April 2018 (Pre-Workshop & General Assembly)\nThursday\, 26th April 2018\nFriday\, 27th April 2018 \nLanguage: Englisch \n\n\n\n\n	Fees \nWorkshop “Pharmacovigilance in early phase drug development – basic terms and key concepts \nBasic principles of immunology” 25 April 2018 \n\n\n\nMember*\n170 EUR\n\n\nNon-Member\n200 EUR\n\n\n\n  \nAGAH Annual Meeting 2018 „Target organs in early medicines development - predictability and prevention of adverse reactions“\,  26-27 April 2018 (early bird until 31 January\, 2018 extended: 07 February 2018) \n\n\n\n\nearly bird\nregular\n\n\n\n\nMember*\n320 EUR\n370 EUR\n\n\nNon-Member\n400 EUR\n470 EUR\n\n\nJunior Scientists\n(under age 30)\n170 EUR\n270 EUR\n\n\nDay Ticket\n\n270 EUR\n\n\nConference-Networking-Dinner\n\n60 EUR\n\n\n\n*of the AGAH\, AHPPI\, BAPU\, Club Phase I\, EUFEMED \n\n\n\n\n	Program committee \nK. Breithaupt-Grögler\, C. Coch\, F. Donath\, K. Erb-Zohar\, C. Hinze\, M. Iovino\, J. Rengelshausen\, B. Schug\, G. Wensing \n\n\n\n\n	Pre-Workshop: Wednesday\, 25th April 2018 \nPharmacovigilance in early phase drug development – basic terms and key concepts\nChairs: K. Breithaupt-Groegler\, Frankfurt (Germany); K. Erb-Zohar\, Hanau (Germany) \n\n13:00 – 13:45 \nIdentification\, assessment\, and communication of adverse events in (early phase) clinical trials\nA. Blank\, Heidelberg (Germany) \n\n13:45 – 14:30 \nIdentification of risks – Key documents on safety information\n(Investigator’s brochure\, company core data sheet\, company core safety information\, summary of product characteristics\, risk management plan\, development safety update report\, periodic safety update report/ periodic risk-benefit evaluation report) \nM. Weber\, Ingelheim am Rhein (Germany) \n\n14:30 – 14:45 Break \n\n14:45 – 15:05 \nUseful tools for the evaluation of adverse events (CTCAE\, designated medical events\, EMA List of important medical events) \nK. Erb-Zohar\, Hanau (Germany) \n\n\n15:05 – 15:45 \nManagement of safety signals in early phase drug development \nU. Vogel\, Ingelheim (Germany) \n\n15:45 – 16:15 \n»Safety Review Committee« in early phase trials \nJ. Graff\, Frankfurt (Germany) \n\n16:15 – 16:30 Break \nStop dose escalation or continue dosing? – Case study developed in break-out groups \nK. Erb-Zohar\, Hanau (Germany) \n\n17:45 – 18:00 Wrap up and end of meeting	 \n\n18:15	Get together \n\n19:00 AGAH General Assembly \n\n\n\n\n	Day 1: Thursday\, 26th April 2018 \n08:45 \nWelcome and Introduction\nB. Schug\, Oberursel (Germany) \n\n09:00 \nHypersensitivity reactions and adverse drug reactions\nSir Munir Pirmohamed\, Liverpool (United Kingdom) \n\nSession 1: Drug-induced renal function impairment\nChairs: M. Boettcher\, Wuppertal (Germany); J. Rengelshausen\, Aachen (Germany) \n\n09:45 – 10:15	 \nRelevant new renal function biomarkers? \nP. Murray\, Dublin (Ireland) \n\n10:15 – 10:45 \nRenal function in early phase trials \nM. Boettcher\, Wuppertal (Germany) \n\n10:45 – 11:15 Break \n\nSession 2: Drug-induced liver injury \nChairs: S. Plassmann\, Munich (Germany); G. Wensing\, Wuppertal (Germany) \n\n11:15 – 11:45 \nSafety assessment of hepatic findings in non-clinical studies \nS. Plassmann\, Munich (Germany) \n\n11:45 – 12:15 \nFindings on hepatic function parameters in early phase trials with healthy subjects \nD. Jung\, Wuppertal (Germany) \n\n12:15 – 12:45 \nClinical interpretation of hepatic safety biomarkers \nM. Merz\, Zurich (Switzerland) \n\n12:45 – 13:00	Discussion \n\n15:45 – 16:15 	Break \n\nSession 3: Drug-induced CNS adverse reactions\nChairs: F. Donath\, Erfurt (Germany); J. Stingl\, Bonn (Germany) \n\n14:00 – 14:30 \nPreclinical Screening for CNS effects of potential drug substances \nM. Traebert\, Basel (Switzerland) \n\n14:30 – 15:00 \nPhysico-chemical drug properties and human CNS system characteristics: determinants of CNS pharmacokinetics at different locations in human brain \nE. de Lange\, Leiden (The Netherlands) \n\n15:00 – 15:30 \nPrediction and detection of off-target drug effects on mental health: from neuronal cell models to neuroimaging \nJ. Stingl\, Bonn (Germany) \n\n15:30-15:45	Discussion \n\n15:45 – 16:15 	Break \n\nSession 4: Drug-induced adverse reactions on the cardiac system\nChairs: M. Iovino\, Biberach; J. Taubel\, London \n\n16:15 – 16:45 \nInfluence of contractility of cardiomyocytes – pathophysiology of cardiac muscle toxicity \nU. Ravens\, Freiburg i. Breisgau (Germany) \n\n16:45 – 17:15 \nQTc assessment strategies in early phase development \nB. Darpo\, Stockholm (Sweden) \n\n17:15 – 17:45 \nWaivers on TQT trials – a critical appraisal \nExpert panel discussion with S. Baumann\, Berlin (Germany); N. Beetz\, Biberach (Germany); B. Darpo\, Stockholm (Sweden); D. Kubitza\, Wuppertal (Germany); J. Taubel\, London (United Kingdom) \n\n19:30	Conference Networking-Dinner \n\n\n\n\n	Day 2: Friday\, 27th April 2018 \nSession 5: Local tolerance in drugs intended for alternate routes of administration \nChairs: E. Roehrdanz\, Bonn (Germany); B. Schug\, Oberursel (Germany) \n\n09:00 – 09:30 \nNon-animal research models: imitation of three-dimensional cavities for risk assessment in respiratory tract  \nS. Constant\, Geneva (Switzerland) \n\n09:30 – 10:00 \nRisk assessment for dermal application: how to estimate skin irritation and sensitisation from animal and in-vitro data \nD. Basketter\, Sharnbrook (United Kingdom) \n\n10:00 – 10:30 \nGuideline on non-clinical local tolerance testing of medicinal products: regulatory perspectives \nE. Roehrdanz\, Bonn (Germany) \n\n10:30 – 10:45	Discussion \n\n10:45 – 11:15	Break \n\nSession 6: Immunotoxicity\nChairs: C. Coch\, Bonn (Germany); J. Descotes\, Lyon (France) \n\n11:15 – 11:45 \nImmunological safety issues in early clinical trials: a translational approach \nJ. Descotes\, Lyon (France) \n\n11:45 – 12:15 \nChallenges and approaches for predicting immunogenicity \nP. Mayer\, Bonn (Germany) \n\n12:15 – 12:55 \nSafety and immunogenecity for Gene Therapy Medicinal Products and Therapeutic Vaccines \nM. Goldammer; N. Kirsch-Stefan\, Langen (Germany) \n\n12:55 – 13:10 	Discussion \n\n13:10 \nConcluding remarks \nG. Wensing\, Wuppertal (Germany) \n\n13:20 \nFarewell lunch \nsubject to modifications\, status February 2018 \n\n\n\n\n\n	Speaker / Chairs \n\nBasketter Daniel\, Dr. 	DABMEB Consultancy Ltd · Sharnbrook/United Kingdom\n\n	Baumann Sybille\, Dr. 	CRS Clinical Research Services Berlin GmbH · Berlin/Germany\n	Beetz Nadine\, Dr. 	Boehringer Ingelheim International GmbH · Biberach/Germany\n	Blank Antje\, Dr. 	Heidelberg University Hospital · Heidelberg/Germany\n	Boettcher Michael 	Bayer Pharma AG · Wuppertal/Germany\n	Breithaupt-Groegler Kerstin\, Dr. 	-kbr- clinical pharmacology services Frankfurt/M./Germany\n	Coch Christoph\, Dr. 	University Hospital Bonn · Bonn/Germany\n	Constant Samuel 	Geneva/Switzerland\n	Darpo Borje\, Prof. 	iCardiac Technologies · Lidingo/Sweden\n	de Lange Elisabeth\, Dr. E.C.M. 	Leiden University · Leiden/The Netherlands\n	Descotes Jacques\, Prof. 	Claude Bernard University · Lyon/France\n	Donath Frank\, Dr. 	SocraTec R&D GmbH · Erfurt/Germany\n	Erb-Zohar Katharina\, Dr. 	clinphase · Hanau/Germany\n	Goldammer\, Mark 	Paul-Ehrlich-Institut · Langen/Germany\n	Graff Jochen\, Dr. 	Frauenhofer IME · Frankfurt /Germany\n	Iovino Mario\, Dr. 	Boehringer Ingelheim International GmbH · Biberach/Germany\n	Jung David\, Dr. 	Bayer Pharma AG · Leverkusen/Germany\n	Kubitza Dagmar\, Dr. 	Bayer AG · Wuppertal/Germany\n	Kirsch-Stefan\, Nadine 	Paul-Ehrlich-Institut · Langen/Germany\n	Mayer Peter\, PD Dr. 	Bundesinstitut für Arzneimittel und Medizinprodukte Bonn/Germany\n	Merz Michael\, Dr. 	UniversityHospital Zurich · Zurich/Switzerland\n	Murray Patrick\, Prof. 	University College Dublin · Dublin/Ireland\n	Sir Munir Pirmohamed\, Prof. Dr. 	University of Liverpool · Liverpool/United Kingdom\n	Plassmann Stephanie\, Dr. 	PreClinical Safety (PCS) Consultants Ltd. · Munich/Germany\n	Ravens Ursula\, Prof. Dr. 	University Heart Center Freiburg Freiburg im Breisgau/Germany\n	Rengelshausen Jens\, Dr. 	Grünenthal GmbH · Aachen/Germany\n	Roehrdanz Elke\, Dr. 	Bundesinstitut für Arzneimittel und Medizinprodukte Bonn/Germany\n	Schug Barbara\, Dr. 	SocraTec R&D GmbH · Oberursel/Germany\n	Stingl Julia\, Prof. Dr. 	Bundesinstitut für Arzneimittel und Medizinprodukte Bonn/Germany\n	Taubel Jorg\, Dr. 	Richmond Pharmacology Ltd. · London/United Kingdom\n	Traebert Martin\, Dr. 	Novartis Pharma AG · Basel /Schweiz\n	Vogel Ulrich\, Dr. 	Boehringer Ingelheim International GmbH Ingelheim am Rhein/Germany\n	Weber Maria\, Dr. 	Boehringer Ingelheim International GmbH · Ingelheim am Rhein/Germany\n	Wensing Georg\, Prof. Dr. 	Bayer Pharma AG · Wuppertal/Germany\n\n\n\n\n\n	Contact and further information \nAssociation for Applied Human Pharmacology (AGAH) e.V.\noffice: Goernestraße 30\n20249 Hamburg \nphone: +49 170 7844438\ne-Mail: info@agah.eu\nWeb: www.agah.eu \n\n\n\n\n	Registration \nCSi Hamburg GmbH\nConferences | Symposia | Incentives\nPCO Professional Conference Organizer\nGoernestraße 30\n20249 Hamburg\nGermany \nphone: +49 40 30770300\nfax: +49 40 30770301\ne-Mail: agah-veranstaltungen@csihamburg.de \nOnline Registration\nwww.csioffice.de/agah2018 \n\n\n\n\n	Downloads \nProgramme \n27th AGAH Annual Meeting 2018 \n\nElizabeth CM de Lange \nPhysico-chemical drug properties and human CNS system characteristics: determinants of CNS PK at different locations in human CNS \n\nNadine Kirsch-Stefan and Mark Goldammer \nSafety and Immunogenicity for Gene Therapy Medicinal Products and Therapeutic Vaccines \n\nAGAH_Basketter_April_27_wide.pdf \nRisk assessment for dermal application ... \n\nMichael Merz \nClinical interpretation of hepatic safety biomarkers \n\nUrsula Ravens \nContractility reduction as adverse drug reaction – pathophysiology of cardiac muscle toxicity \n\nBorje Darpo \nECG Assessment in Early Clinical Trials \n\nElke Röhrdanz \nGuideline on non-clinical local tolerance testing of medicinal products: regulatory perspectives \n\nJacques Descotes \nImmunological Safety Issues in Early Clinical Trials: A translational approach \n\nStephanie Plassmann \nSafety assessment of hepatic findings in non-clinical studies \n\nMartin Traebert \nPreclinical Screening for CNS effects of potential drug substances \n\nJulia C. Stingl \nPrediction and detection of off-target drug effects on mental health: from neuronal cell models to neuroimaging
URL:https://dev.agah.eu/event/27th-agah-annual-meeting-2018-2/
LOCATION:Annual Meeting 2018\, München\, Deutschland
CATEGORIES:Annual Meetings
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