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DTSTART:20190331T010000
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DTSTART;VALUE=DATE:20190402
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DTSTAMP:20260929T014456
CREATED:20190422T145849Z
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UID:1895-1554163200-1554508799@dev.agah.eu
SUMMARY:Introductory Course in Exploratory Medicines Development – Part II
DESCRIPTION:This course addresses postgraduates in life sciences interested in early clinical development of medicinal products. Two training parts of several days provide a concise overview on Human Pharmacology / Translational Medicine spanning from non-clinical pharmacology and toxicology over first-in-man studies to proof-of-concept clinical trials. \nThis AGAH course meets the standards for high-quality postgraduate education and training in Medicines Development established by PharmaTrain and has been awarded a PharmaTrain Recognition. The course (Parts I plus II) was accredited 3 ECTS. \n\n\n\n	 \nIntroduction and Learning Outcomes \n \nThis course addresses postgraduates in life sciences interested in early clinical development of medicinal products. Two training parts of several days provide a concise overview on Human Pharmacology / Translational Medicine spanning from non-clinical pharmacology and toxicology over first-in-man studies to proof-of-concept clinical trials. \nLearning Outcomes \nOn successful completion of Part II\, students should be able to demonstrate an understanding / knowledge of the following: \n\nnonclinical pharmacology and toxicology\nmolecular basis of drug actions\nallometric scaling and dose proportionality assessments based on characteristic PK data\ndefining pharmacodynamic (PD) endpoints and biomarkers\ndifferentiating between primary and secondary PK and PD endpoints\nHow to design an early clinical pharmacology developmant plan\nplanning and management of a first-in-man trial\nprinciples of data management and information flow\nprinciples of reporting and publication\nprinciples of medical statistics\ncharacteristic issues involved in the development of biologicals and biosimilars\n\nThis AGAH course meets the standards for high-quality postgraduate education and training in Medicines Development established by PharmaTrain and has been awarded a PharmaTrain Recognition. The course (in 2016/17) was accredited 3 ECTS (Parts I plus II). \n\n\n\n\n	 \nDay 1: Tuesday\, 2nd April 2019\n \n10:00 – 10:15 \nIntroduction of faculty and participants \n\n10:15 – 10:30 \nOverview on Part II training course \n\n10:30 – 12:00 \nMolecular basis of drug action: Receptor pharmacology\, agonists\, antagonists\, second messengers\, enzymes\, regulatory proteins\, transcription factors\, cellular sites of drug actions \nMartin Coenen \n\n12:00 – 13:00 \nBreak \n\n13:15 – 14:45 \nPharmacodynamic endpoints and biomarker: Biomarkers for stratified medicine\, companion diagnostics and proof of concept; biomarkers and PD endpoints in oncology\, diabetes\, car diovascular diseases\, cardiac safety and in pain \nJens Rengelshausen  \n\n14:45 – 15:00 \nBreak \n\n15:00 – 18:30 \nAssessment of non-clinical data and risk as prerequisites before administration to man: Compound selection\, early in vivo studies including primary and secondary pharmacodynamics and -kinetics\, safety pharmacology\, general toxicology in various species (rodents\, non-rodents) including NOEL/NOAEL and MTD\, safety ratio\, toxicokinetics\, genotoxicity\, immunotoxicity\, local tolerance\, phototoxicity \nStephanie Plassmann \n\n18:30 – 20:30 \nGet together and formation of break-out groups \n  \n\n\n\n\n	 \nDay 2: Wednesday\, 3rd April 2019\n \n  \n08:45 – 10:45 \nAssessment of non-clinical data and risk as prerequisites before administration to man:Compound selection\, early in vivo studies including primary and secondary pharmacodynamics and -kinetics\, safety pharmacology\, general toxicology in various species (rodents\, non-rodents) including NOEL/NOAEL and MTD\, toxicokinetics\, genotoxicity\, immunotoxicity\, local tolerance\, phototoxicity \nStephanie Plassmann \n\n10:45 – 11:00 \nBreak \n\n11:00 – 11:30 \nThe revised EMA guideline on early phase clinical trials – key elements \nKerstin Breithaupt-Grögler \n\n11:30 – 12:45 \nHow to determine a safe starting dose for first-in-human? Key safety parameters\, case study developed in break-out groups \nStephanie Plassmann \n\n12:45-13:45 \nBreak \n\n13:45 – 14:45 \nHow to determine a safe starting dose for first-in-human? Presentations of case study \nStephanie Plassmann \n\n14:45 – 16:15 \nPharmacokinetics III: PK linearity / non-linearity / dose proportionality assessments\, biopharmaceutics classification system (BCS)\, absorption half-life\, flip-flop kinetics\, protein binding\, 14C-studies (mass balance studies)\, allometric scaling \nAndreas Kovar \n\n16:15-16:30 \nBreak \n\n16:30 – 17:00 \nQuiz on essential terms: questions and answers provided by the audience \nKerstin Breithaupt-Grögler \n\n\n\n\n	 \nDay 3: Thursday\, 4th April 2019\n \n  \n09:00 – 10:00 \nStop dose escalation or continue dosing? Case study developed in break-out groups \nKatharina Erb-Zohar \n\n10:00 – 10:15 \nBreak \n\n10:15 – 11:00 \nStop dose escalation or continue dosing?Presentation of case studies \nKatharina Erb-Zohar \n\n11:00 – 12:15 \nHow to design a first-in-human trial? Development of case study in break-out groups \nKarin Göhler \n\n12:15 – 13:15 \nBreak \n\n13:15 – 14:00 \nHow to design a first-in-human trial? Presentations of case study \nKarin Göhler \n\n14:00 – 14:15 \nBreak \n\n14:15 – 16:00 \nHow to proceed from single ascending dose to multiple ascending dose? Assessment and evaluation of SAD safety and PK data\, integrated protocols versus consecutive trials\nKarin Göhler \n\n16:00 – 16:15 \nBreak \n\n16:15 – 18:00 \nHow to design an early clinical pharmacology development program? Basic concepts of early phase trials supporting early clinical development and decision making \nKarin Göhler \n\n\n\n\n	 \nDay 4: Friday\, 5th April 2019\n \n08:45 – 09:15 \nFlow of information and reporting of trial data \nKerstin Breithaupt-Grögler \n\n09:15 – 09:45 \nData management: Principles\, electronic / paper CRFs\, queries\, data cleaning\, data base closure \nManfred Wargenau \n\n09:45 – 10:00 \nBreak \n\n10:00 – 10:45 \nMonitoring and Auditing: An essential tool to ensure credibility of data \nChristian Hinze \n\n10:45 – 11:00 \nBreak \n\n11:00 – 12:45 \nAnalysis of early exploratory development studies – principles of medical statistics: Differences between treatments regarding biomarkers\, pharmacokinetic / -dynamic effects\, safety\, parametric vs. non-parametric analysis\, t-tests\, repeated measures ANOVA\, parametric vs. non-parametric analysis\, Chi-square\, Fisher's exact \nManfred Wargenau \n\n12:45 – 13:30 \nBreak \n\n13:30 – 14:15 \nAnalysis of early exploratory development studies - principles of medical statistics (continued) \n\n14:15 – 16:00 \nIntroduction to biologicals and biosimilars  \nHildegard Sourgens \n\n16:00 – 16:15 \nBreak \n\n16:15 – 16:45 \nMandatory Test on Part II (50% of questions must be correctly answered to pass test and receive a certificate) \n\n16:45 – 17:00 \nFeed back and end of Part II \n\n\n\n\n	 \nAttendance Fees\n \n\n\n\n1.100 €\n1.450 €\nMembers of the AGAH\, AHPPI\, BAPU\, Club Phase I\, EUFEMED\nNon-Members\n\n\n1.900 € \n2.500 € \n\nPart I plus II\nfor Members of the AGAH\, AHPPI\, BAPU\, Club Phase I\, EUFEMED \nPart I plus II for Non-Members \n\n\n\n\nSpecial fees for students are available on request \n\n\n\n\n	 \nVenue\n \nSocraTec R&D GmbH\nIm Setzling 35\n61440 Oberursel \n\n\n\n\n	 \nContact and further information\n \nAssociation for Applied Human Pharmacology (AGAH) e. V.\noffice: Goernestraße 30\n20249 Hamburg \nphone: +49 40 30772097\ne-Mail: info ( a t ) agah.eu\nWeb:   www.agah.eu \n\n\n\n\n	 \nDownloads\n \nProgramm: ICiEM 2019 PartII \nRegistration Form: ICiEM 2019
URL:https://dev.agah.eu/event/introductory-course-in-exploratory-medicines-development-part-ii/
LOCATION:AGAH Workshop\, Oberursel\, Deutschland
CATEGORIES:Workshops
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