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X-WR-CALDESC:Veranstaltungen für AGAH
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DTSTART:20150329T010000
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DTSTART;VALUE=DATE:20150422
DTEND;VALUE=DATE:20150425
DTSTAMP:20260929T014811
CREATED:20190604T210537Z
LAST-MODIFIED:20190624T232648Z
UID:2554-1429660800-1429919999@dev.agah.eu
SUMMARY:Introductory Course in Early Medicines Development
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\nInformationen\n\n\nIntroductory Course in Early Medicines Development\n22. – 24.04.2015 in Oberursel bei Frankfurt\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\nmethod validation according to good clinical (GCP) and good laboratory (GLP) practise\nplanning and management of a first-in-man trial\npractical aspects of bioequivalence trials\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\, 22 April 2015\n\n\n\n\n12:00 – 12:15\nIntroduction of faculty and participants \nAll \n\n\n\n12:15 – 12:30\nOverview on Part II training course \nAll \n\n\n\n12:30 – 14:00\nMolecular basis of drug action (receptor pharmacology\, agonists\, antagonists\, second messengers\, enzymes\, regulatory proteins\, transcription factors\, cellular site of drug action \nMartin Coenen \n\n\n\n14:00 – 14:15\nBreak\n\n\n14:15 – 16:15\nPharmacodynamic endpoints and biomarkers (cardiovascular\, CNS\, diabetes\, immunology\, challenging substances\, stress tests\, cardiac safety / QTc trial)\, proof of concept (POM\, POC)\nJens Rengelshausen\n\n\n16:15 – 16:30\nBreak\n\n\n16:30 – 18:30\nNonclinical development: compound selection (in silico\, in vitro assays\, early in vivo studies incl. primary and secondary pharmacodynamics and kinetics); safety pharmacology\, general toxicology in various species [rodents\, non-rodents] incl. NOEL/NOAEL and MTD \nStephanie Plassmann\, Hildegard Sourgens\n \n\n\n\n\n\n\n\n\n\nDay 2: Thursday\, 23 April 2015\n\n\n\n\n08:45 – 09:45\nGCP / GLP – focus on method validation: bioanalytics\, sample collection\, sample preparation\, quality assurance procedures \nBarbara Schug \n\n\n\n09:45 – 10:45\nBioequivalence trials: Design development and realization –practical examples. Specific aspects besides the classical standard design\nBarbara Schug\n\n\n10:45 – 11:15\nBreak\n\n\n11:15- 13:15\nNonclinical development: genetic toxicology\, immunotoxicology\, local tolerance\, phototoxicity\, reproductive toxicity\nStephanie Plassmann\, Hildegard Sourgens\n\n\n\n13:15 – 14:15\nBreak\n\n\n14:15 – 15:30\nPharmacokinetics: allometric scaling\, 14C-studies\,  absorption half-life\, flip-flop kinetics\, protein binding\,  PK linearity / non-linearity\, dose proportionality assessments\, biopharmaceutics classification system \nAndreas Kovar\n \n\n\n\n15:30 – 15:45\nBreak\n\n\n15:45 – 17:00\nKey safety parameters to characterise and determination of a safe starting dose for FIM – case studies \nStephanie Plassmann \n\n\n\n17:00 – 17:15\nBreak\n\n\n17:15 – 18:15\nCase study: stop dose escalation or continue dosing?\nKatharina Erb-Zohar\n\n\n19:30\nDinner Meeting\n\n\n\n\n\n\n\n\nDay 3: Friday\, 24 April 2015\n\n\n\n\n08:45 –\n09:15\nData management \nManfred Wargenau \n\n\n\n09:15 –\n09:45\nFlow of information / reporting and publication \nKerstin Breithaupt-Grögler \n\n\n\n09:45 –\n10:15\nBreak\n\n\n10:15 –\n13:00\nPrinciples of medical statistics: differences between treatments regarding biomarkers\, pharmacodynamic effects\, and safety\, e.g.\, t-tests\, repeated measures ANOVA\, parametric vs. non-parametric analysis\, Chi-square\, Fisher’s exact \nManfred Wargenau \n\n\n\n13:00 –\n14:00\n Break\n\n\n14:00 –\n15:45\nIntroduction to biologicals and biosimilars\nHildegard Sourgens\n\n\n15:45 –\n16:30\nTest on Part II contents of Human Pharmacology Training; \nparticipation in test is mandatory to receive the certificate of attendance! \nAll \n\n\n\n16:30 –\n17:00\nFeed back \nAll \n\n\n\n17:00\nEnd 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\n\nSpecial fees for students are available on request. \nThis meeting will be accredited by the Landesärztekammer\, participants will be awarded ”Fortbildungspunkte”. More information will be provided in due time. \n\n\n\n\nContact\n\nRegistration | Workshop Office: \nCSi Hamburg GmbH\nJungfrauenthal 22\nD-20149 Hamburg\nPhone: +49 40 307720 97\nTelefax: +49 40 846097 60\nE-Mail: agah-veranstaltungen ( a t ) csihamburg.de \n\n\n\nVenue\n\nSocraTec R&D GmbH\nIm Setzling 35\n61440 Oberursel \n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\nDownloads\nAGAH_ICiTM_Registration_form_Part2only
URL:https://dev.agah.eu/event/introductory-course-in-early-medicines-development/
LOCATION:AGAH Workshop\, Oberursel\, Deutschland
CATEGORIES:Workshops
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