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DTSTART;VALUE=DATE:20170201
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DTSTAMP:20260929T022910
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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 2.5 days each 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. \n\n\n\n\n\n\n\n\n\n\n\nInformation\n\n\nAGAH-Workshop “Introductory Course in Exploratory Medicines Development – Part II”\n1. – 3.2.2017 in Oberursel\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\n\n\n\n\nDay 1: Wednesday\, 01 February 2017\n\n\n\n\nTime\nContent\n\n\n09:00 – 09:15\nIntroduction of faculty and participants\n\n\n09:15 – 09:30\nOverview on Part II training course\n\n\n09:30 – 11:00\nMolecular basis of drug action: Receptor pharmacology\, agonists\, antagonists\, second messengers\, enzymes\, regulatory proteins\, transcription factors\, cellular sites of drug actions \nDr. M. Coenen \n\n\n\n11:00 – 11:15\nBreak\n\n\n11:15 – 13:00\nPharmacodynamic endpoints and biomarker: Cardiovascular\, CNS\, diabetes\, immunology\, challenging substances\, stress tests\, cardiac safety / QTc\, how to assess proof of concept (PoM\, PoC)\nDr. J. Rengelshausen or Dr. M. Zühlsdorf\n\n\n13:00 – 14:00\nBreak\n\n\n14:00 – 17:30\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\, toxicokinetics\, genotoxicity\, immunotoxicity\, local tolerance\, phototoxicity\nDr. S. Plassmann or Prof. Dr. H. Sourgens\n\n\n17:30 – 17:45\nBreak\n\n\n17:45 – 18:45\nHow to determine a safe starting dose for first-in-human? Key safety parameters\, presentation of case studies \nDr. S. Plassmann \n\n\n\n\n\n\n\n\n\nDay 2: Thursday\, 02 February 2017\n\n\n\n\n08:45 – 09:45\nHow to determine a safe starting dose for first-in-human? Key safety parameters\, presentation of case studies\nDr. S. Plassmann \n\n\n\n09:45 – 10:00\nBreak\n\n\n10:00 – 12:00\nPharmacokinetics III: PK linearity / non-linearity\, dose proportionality assessments\, allometric scaling\, 14C-studies\, absorption half-life\, flip-flop kinetics\, protein binding\, biopharmaceutics classification system\nDr. A. Kovar\n\n\n\n12:00 – 12:45\nStop dose escalation or continue dosing?\nCase study developed in break-out groups\nDr. K. Erb-Zohar\n\n\n12:45 – 13:30\nBreak\n\n\n13:30 – 14:15\nStop dose escalation or continue dosing? Case study developed in break-out groups \nDr. K. Erb-Zohar \n\n\n\n14:15 – 14:30\nBreak\n\n\n14:30 – 18:00\nHow to design an early clinical pharmacology development program? Basic concepts of FIM trial and early clinical pharmacology trials supporting early clinical development and decision making. Case study developed in break-out groups \nDr. K. Göhler \n\n\n\n\n\n\n\n\n\nDay 3: Friday\, 03 February 2017\n\n\n\n\n08:45 – 09:15\nData management: Principles\, electronic / paper CRFs\, queries\, data cleaning\, data base closure\nDr. M. Wargenau\n\n\n09:15 – 09:45\nReporting and publication: Flow of information\, types of reports\, guidelines\, abstracts and full papers\nDr. K. Breithaupt-Grögler \n\n\n09:45 – 10:00\nBreak\n\n\n10:00 – 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\nDr. M. Wargenau\n\n\n12:45 – 13:45\nBreak\n\n\n13:45 – 15:45\nIntroduction to biologicals and biosimilars\nProf. Dr. H. Sourgens\n\n\n15:45 – 16:30\nMandatory Test on Part I\n(50% of questions must be correctly answered to pass test and receive a certificate)\n\n\n16:30 – 17:00\nFeed back and end of Part II\n\n\n\n\n\n\n\n\nAttendance Fees\n\n\n\n\n1.100 €\n1.450 €\nMembers of the AGAH\, BAPU\, Club Phase I\, AHPPI\, DGPharMed\, DGKliPha\nNon-Members\n\n\n1.900 € \n2.500 € \n\nPart I plus II\nfor Members of the AGAH\, BAPU\, Club Phase I\, AHPPI\, DGPharMed\, DGKliPha \nPart I plus II for Non-Members \n\n\n\n\nSpecial fees for students are available on request \nThis course will be accredited by the Landesärztekammer\, participants will be awarded ”Fortbildungspunkte”.\nMore information will be given in due time \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 \nThis workshop is supported by PreClinical Safety (PCS) Consultants Ltd.\n\n\n\nRegistration\n\nCSi Hamburg GmbH\nConferences | Symposia | Incentives\nGoernestraße 30\n20249 Hamburg\nGermany \nphone: +49 40 30770300\nfax:    +49 40 30770301\ne-Mail: agah-veranstaltungen ( a t ) csihamburg.de \n\n\n\n\n\n\n\n\n\n\nDownloads\nAGAH_ICiEM_Registration_form \nAGAH_Programme_IciEM_PartII
URL:https://dev.agah.eu/event/introductory-course-in-exploratory-medicines-development-part-ii-4/
LOCATION:AGAH Workshop\, Oberursel\, Deutschland
CATEGORIES:Training
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