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DTSTART:20140330T010000
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DTSTART:20141026T010000
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DTSTART;VALUE=DATE:20140213
DTEND;VALUE=DATE:20140216
DTSTAMP:20260929T020400
CREATED:20190604T211944Z
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SUMMARY:Introductory Course on Human Pharmacology / Translational Medicine – Part II
DESCRIPTION:This course provides a basic training in Human Pharmacology / Translational Medicine and is addressed to postgraduates in life sciences interested in early clinical development of medicinal products. \n\n\n\n	Information \n\n\nIntroduction and Learning Outcomes\n\nThis course provides a basic training in Human Pharmacology and is addressed to postgraduates in life sciences interested in early clinical development of medicinal products. \nLearning Outcomes \nOn successful completion of Part 2 of this course\, students should be able to demonstrate an understanding / knowledge of the following: \n\nintegration of pertinent available scientific information into an IB and a clinical trial protocol\nspecific aspects of how to set-up and conduct early phase clinical trials\ndefining endpoints for early phase clinical trials\ndifferentiating between primary and secondary endpoints\nassessment and evaluation of safety data from clinical trials\nGCP / GLP method validation\nprinciples of medical statistics\nprinciples of data management and information flow\nmolecular basis of drug action\ndevelopment of biologicals and biosimilars\n\n\n\n\n\nDay 1: Thursday\, 13 February 2014\n\n\n\n\n08:45 – 09:00\nIntroduction of faculty and participants \nAll \n\n\n\n09:00 – 09:15\nOverview on Part II training course \nAll \n\n\n\n09:15 – 10:45\nPharmacokinetics III: 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\n10:45 – 11:15\nBreak\n\n\n11:15 – 12:15\nDetermination of safe starting dose for FIM – case studies\nStephanie Plassmann\n\n\n12:15 – 13:00\nNonclinical toxicology II: reprotoxicology\nStephanie Plassmann\n\n\n13:00 – 14:00\nLunch Break\n\n\n14:00 – 14:45\nTrial protocol and investigator's brochure – how to integrate information from scientific literature\, nonclinical / clinical information and other sources\, primary and secondary endpoints\nKerstin Breithaupt \n\n\n14:45 – 16:15\nConduct of clinical trials \n- SITE SELECTION: contracts\, recruitment\, auditing \n- Practical aspects of Phase I studies in patients \n- Quality management in clinical trials\nAntje Blank  / Katharina Erb-Zohar / Christian Hinze \n\n\n\n16:15 – 16:30\nBreak\n\n\n16:30 – 18:00\nSafety parameters and stopping criteria (AE\, SAE\, ADR\, SUSAR\, relationship to trial medication\, severity of AE\, liver / renal toxicity\, general tolerability\, local tolerance\, monitoring of vital signs)\nAntje Blank / Georg Wensing \n\n\n\n\n\n\n\n\nDay 2: Friday\, 14 February 2014\n\n\n\n\n08:45 – 09:30\nSubject informed consent: How to inform healthy subjects and patients about an early phase clinical trial? \nKerstin Breithaupt /  Antje Blank  \n\n\n\n09:30 – 10:30\nGCP / GLP – focus on method validation: bioanalytics\, sample collection\, sample preparation\, quality assurance procedures \nBarbara Schug \n\n\n\n10:30 – 10:45\nBreak\n\n\n10:45 – 11:30\nPK/PD trials in drug-device combinations: inhaled glucocorticoids as example for complex early clinical development plans \nBarbara Schug \n\n\n\n11:30 – 13:00\nSpecific aspects of first-in man trials: FDA and EMA Guidances on FIM; trial medication; examples for typical dose escalation schemes / designs\, safety and PK / PD endpoints; when should dose escalation be stopped? \nMaria Burian / Sybille Baumann \n\n\n\n13:00 – 14:00\nLunch Break\n\n\n14:00 – 15:15\nCase study: stop dose escalation or continue dosing? \nKatharina Erb-Zohar / Maria Burian \n\n\n\n15:15 – 16:00\nData management and cleaning\, flow of information\, reporting \nKerstin Breithaupt / Manfred Wargenau \n\n\n\n16:00 – 16:15\nBreak\n\n\n16:15 – 18:00\nPrinciples of medical statistics: definition of analyses populations (safety\, ITT\, FAS\, PP)\, principles of statistical testing\, statistical significance and power\, confidence intervals\, ANOVA\, ANCOVA\, repeated measures\, multiple tests\, parametric vs. non-parametric analysis\, Chi-square\, Fisher's exact) \nManfred Wargenau \n\n\n\n19:00\nDinner Meeting\n\n\n\n\n\n\n\n\nDay 3: Saturday\, 15 February 2014\n\n\n\n\n08:30 – 10:00\nMolecular basis of drug action (receptor pharmacology\, agonists\, antagonists\, second messengers\, enzymes\, regulatory proteins\, transcription factors\, cellular sites of drug actions) \nMartin Coenen / Christoph Coch \n\n\n\n10:00 – 10:15\nBreak\n\n\n10:15 – 11:15\nIntroduction to biologicals and biosimilars \nHildegard Sourgens \n\n\n\n11:15 – 11:30\nBreak\n\n\n11:30 – 12:15\nTest on Part II contents of Human Pharmacology Training; \nPlease respect regarding travelling arrangements: participation in test is mandatory to receive the certificate of attendance! \nAll \n\n\n\n12:15 – 12:30\nFeed back \nAll \n\n\n\n12:30\nEnd of Part II and Farewell Lunch\n\n\n\n\n\n\n\n\n\n\n\n\nAttendance Fees\n\n\n\n\n1.250 €\nNon-Members\n\n\n1.000 €\nMember of the AGAH\, DGPharMed\, DGKliPha\, BAPU\, Club Phase I\, AHPPI\n\n\n750 €\nStudents\n\n\n\nThis meeting is accredited by the Landesärztekammer\, participants will be awarded ”Fortbildungspunkte”. \n\n\n\n\nContact\n\nRegistration | Workshop Office: \nCSi Hamburg GmbH\nFalkenried 88\nD-20251 Hamburg\nPhone: +49 40 307720 97\nTelefax: +49 40 846097 60\nE-Mail: agah-veranstaltungen ( a t ) csihamburg.de \n\n\n\nVenue\n\nSeminarzentrum und Gästehaus der SRH Business Academy GmbH Bonhoefferstraße 12 69123 Heidelberg \n\n\n\nRegistration\n\nMay we please ask you to use the registration form. \nAGAH_Course_THE_BASICS_OF_HUMAN_PHARMACOLOGY_Registration_form (2) \nAGAH_Course_THE_BASICS_OF_HUMAN_PHARMACOLOGY_Registration_form (3) \nAGAH_Course_THE_BASICS_OF_HUMAN_PHARMACOLOGY_Registration_form (4) \nAGAH_Course_THE_BASICS_OF_HUMAN_PHARMACOLOGY_Registration_form (5) \nAGAH_Course_THE_BASICS_OF_HUMAN_PHARMACOLOGY_Registration_form \nAGAH_Course_THE_BASICS_OF_HUMAN_PHARMACOLOGY_Registration_form (6) \nAGAH_Course_THE_BASICS_OF_HUMAN_PHARMACOLOGY_Registration_form (1)
URL:https://dev.agah.eu/event/introductory-course-on-human-pharmacology-translational-medicine-part-ii-2/
LOCATION:AGAH Workshop\, Heidelberg\, Deutschland
CATEGORIES:Training
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