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X-ORIGINAL-URL:https://dev.agah.eu
X-WR-CALDESC:Veranstaltungen für AGAH
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DTSTART;VALUE=DATE:20210930
DTEND;VALUE=DATE:20211005
DTSTAMP:20260929T023339
CREATED:20220201T105722Z
LAST-MODIFIED:20210825T132122Z
UID:4447-1632960000-1633391999@dev.agah.eu
SUMMARY:Introductory Course in Exploratory Medicines Development - Part I
DESCRIPTION:INTRODUCTION and Learning Outcomes \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 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\nmethod validation according to good clinical (GCP) and good laboratory (GLP) practise practical aspects of bioequivalence trials\n\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 2\, 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 previous courses  were accredited 3 ECTS (Parts I plus II). \n\n\n\n\n	PROGRAMM \nAGAH_ICiEM2021_PartI_30SEP-4OCT \n\n\n\n\n	ANMELDUNG \nZUR ANMELDUNG \nPlätze begrenzt \n  \n\n\n\n\n	KONTAKT und weitere Informationen \nCSi Hamburg GmbH\nGoernestraße 30\n20249 Hamburg (Germany) \n+49 40 30770300\nE-Mail \n\n\n			Kurs ausgebucht. Warteliste aktiv. Bitte Registrierungsform verwenden!
URL:https://dev.agah.eu/event/introductory-course-in-exploratory-medicines-development-part-i-und-ii-oktober-und-november-2021/
LOCATION:digitale Veranstaltung/digital event
CATEGORIES:Termine,Workshops
ORGANIZER;CN="AGAH%20e.%20V.":MAILTO:agah-meetings@csihamburg.de
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