BEGIN:VCALENDAR
VERSION:2.0
PRODID:-//AGAH - ECPv5.16.4//NONSGML v1.0//EN
CALSCALE:GREGORIAN
METHOD:PUBLISH
X-WR-CALNAME:AGAH
X-ORIGINAL-URL:https://dev.agah.eu
X-WR-CALDESC:Veranstaltungen für AGAH
BEGIN:VTIMEZONE
TZID:Europe/Berlin
BEGIN:DAYLIGHT
TZOFFSETFROM:+0100
TZOFFSETTO:+0200
TZNAME:CEST
DTSTART:20200329T010000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:+0200
TZOFFSETTO:+0100
TZNAME:CET
DTSTART:20201025T010000
END:STANDARD
END:VTIMEZONE
BEGIN:VEVENT
DTSTART;VALUE=DATE:20200129
DTEND;VALUE=DATE:20200201
DTSTAMP:20260929T021357
CREATED:20190919T150001Z
LAST-MODIFIED:20200124T144407Z
UID:3884-1580256000-1580515199@dev.agah.eu
SUMMARY:Introductory Course in Exploratory Medicines Development - Part I                 -course fully booked-
DESCRIPTION:We also refer to  Part II \n\n\n\n	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\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	PROGRAM \nDownload: AGAH_ICiEM2020_PartI \n\n\n\n\n	REGISTRATION & Attendance fee \n-course fully booked- \nDownload registration form: AGAH_ICiEM_Registration_form \n\n\n\n\n	CONTACT and further information \nCSi Hamburg GmbH\nGoernestraße 30\n20249 Hamburg (Germany) \nphone: +49 40 30770300\nagah-meetings@csihamburg.de
URL:https://dev.agah.eu/event/introductory-course-in-exploratory-medicines-development-part-i-8/
LOCATION:Königstein (Germany)\, Deutschland
CATEGORIES:Workshops
ORGANIZER;CN="AGAH%20e.%20V.":MAILTO:agah-meetings@csihamburg.de
END:VEVENT
END:VCALENDAR