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DTSTART:20150329T010000
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DTSTART;VALUE=DATE:20150217
DTEND;VALUE=DATE:20150220
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SUMMARY:Introductory Course in Early Medicines Development – Part I
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\nInformations\n\n\nIntroductory Course in Early Medicines Development – Part I\n17.02.2015 – 19.02.2015 in Frankfurt am Main\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 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 1\, students should be able to demonstrate an understanding / knowledge of the following: \n\nprincipal steps in drug development – from compound selection to marketing application and beyond\npertinent issues involved in the undertaking of early clinical research\nspecific aspects of how to set-up and conduct early phase clinical trials\nregulation of medicines in Europe\ndevelopment and review of compound-specific information to ensure adherence to scientific\, medical\, ethical\, and legal provisions\nintegration of pertinent available scientific information into an IB and a clinical trial protocol\nprinciples of trial design\, protocol submission and clinical conduct\nselection of appropriate trial population\nmost common early phase clinical trials and their specific requirements\nassessment and evaluation of safety data from clinical trials\nrelevance of formulation properties and in vitro characteristics of the trial medication for design and planning of an early phase clinical trial\nbasics of pharmacokinetics\ndefining pharmacokinetic (PK) endpoints for early phase clinical trials\n\n\n\n\n\nDay 1: Tuesday\, 17 February 2015\n\n\n\n\n08:45 – 09:15\nIntroduction of faculty and participants \nWolfgang Timmer\, Kerstin Breithaupt \n\n\n\n09:15 – 09:30\nOverview on Part I training course \nWolfgang Timmer\, Kerstin Breithaupt \n\n\n\n09:30 – 10:30\nOverview on the process of clinical drug development (nonclinical studies\, evaluation of toxicity\, pharmacokinetics\, pharmacodynamics\, first-in-man\, Phase 0\, Phases I to III\, exploratory vs. confirmatory trials\, Phase IV\, non-interventional studies / post-marketing surveillance\, epidemiological studies) \nKerstin Breithaupt \n\n\n\n10:30 – 11:00\nBreak\n\n\n11:00 – 12:00\nDesign elements of human pharmacology trials (populations\, number of patients in Phase I\, randomisation procedures\, controlled\, placebo\, staggered timing\, cross-over\, parallel-group\, single-blind\, double-blind\, dose-escalation\, single dose\, multiple dose\, etc.)\nWolfgang Timmer\n\n\n12:00 – 12:45\nRegulatory and ethical aspects of trial conduct I (risk-benefit evaluation\, Declaration of Helsinki\, EU-Directives\, ICH-Guidelines) \nKerstin Breithaupt \n\n\n\n12:45 – 13:45\nBreak\n\n\n13:45 – 14:45\nRegulatory and ethical aspects of trial conduct II (trial authorisation: ethics committee favourable opinion and competent authority approval\, submission and marketing authorisation) \nKerstin Breithaupt \n\n\n\n14:45 – 15:30\nTrial protocol and investigator’s brochure – how to integrate information from scientific literature\, nonclinical / clinical information and other sources; differences IB vs. IMPD; primary and secondary objectives vs. endpoints \nKerstin Breithaupt \n\n\n\n15:30 – 16:00\nBreak\n\n\n16:00 – 18:00\nSelection of trial population and definition of inclusion / exclusion criteria in early drug development (healthy subjects [special emphasis on „when is a subject healthy“?]\, symptomatic subjects\, patients [proof of concept]\, children\, elderly\, gender\, ethnicities\, cultural differences) \nKatharina Erb-Zohar\, Jörg Täubel \n\n\n\n\n\n\n\n\n\nDay 2: Wednesday\, 18 February 2015\n\n\n\n\n08:45 – 10:15\nMost common clinical pharmacology trials: FIM\, safety\, exploratory PK and PD\, PoC trials\, drug-drug-interaction\, drug-food interaction\, bioavailability\, bioequivalence\, QTc trial\, adaptive designs\, basic concepts of clinical development planning \nWolfgang Timmer  \n\n\n\n10:15 – 10:45\nConduct of clinical trials – site selection \nKatharina Erb-Zohar \n\n\n\n10:45 – 11:15\nBreak\n\n\n11:15 – 11:45\nConduct of clinical trials – practical aspects of Phase I studies \nKatharina Erb-Zohar \n\n\n\n11:45 – 12:30\nSubject informed consent: How to inform healthy subjects or patients about an early phase clinical trial? \nKerstin Breithaupt \n\n\n\n12:30 – 13:30\nBreak\n\n\n13:30 – 15:00\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) \nGeorg Wensing \n\n\n\n15:00 – 15:30\nBreak\n\n\n15:30 – 17:00\nTrial medication (drug substance / product\, route of administration\, formulations / drug-food interaction\, specific aspects of preparation / administration / storage in Phase I\, drug accountability\, test / reference therapy\, blinding\, double-dummy\, challenging substances\, labelling\, stabilisation\, IMPD information\, Non-IMPD medication\, code breaking envelopes / emergency unblinding\, release process according to ANNEX 13) \nBarbara Schug \n\n\n\n17:00 – 18:00\nQuestions and answers \nKerstin Breithaupt\, Barbara Schug\, Georg Wensing\, Wolfgang Timmer\n \n\n\n\n19:30\nDinner Meeting\n\n\n\n\n\n\n\n\nDay 3: Thursday\, 19 February 2015\n\n\n\n\n08:30 –\n09:45\nPharmacokinetics I: ADME\, drug-drug interaction\, drug-food interaction\, bioequivalence / bioavailability\, steady state\, accumulation factors \nAndreas Kovar \n\n\n\n09:45 –\n10:00\nBreak\n\n\n10:00 –\n11:15\nPharmacokinetics II: pharmacogenetics / polymorphisms\, pharmacometrics\, PK/PD relationship \nAndreas Kovar \n\n\n\n11:15 –\n12:15\nConduct of clinical trials – monitoring \nChristian Hinze \n\n\n\n12:15 –\n12:30\nBreak\n\n\n12:30 –\n13:15\nTest on Part I contents of Human Pharmacology Training; \nparticipation in test is mandatory to receive the certificate of attendance! \nKerstin Breithaupt\, Christian Hinze \n\n\n\n13:15 –\n13:45\nFeed back Part I \nKerstin Breithaupt\, Christian Hinze \n\n\n\n13:45 –\n14:30\nFarewell Lunch and end of Part I\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\n1900 € \n2500 € \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 meeting will be accredited by the Landesärztekammer\, participants will be awarded ”Fortbildungspunkte”.\nMore information will be given 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\nDAS SPENERHAUS\nHotel und Tagungszentrum am Dominikanerkloster\nDominikanergasse 5\n60311 Frankfurt am Main \n\n\n\n\n\n\n\n\n\n\nDownloads\nAGAH_ICiTM_Registration_form_all_2015
URL:https://dev.agah.eu/event/introductory-course-in-early-medicines-development-part-i/
LOCATION:Spenerhaus\, Frankfurt am Main\, Deutschland
CATEGORIES:Workshops
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