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X-ORIGINAL-URL:https://dev.agah.eu
X-WR-CALDESC:Veranstaltungen für AGAH
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DTSTART:20220327T010000
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DTSTART;TZID=Europe/Berlin:20221118T160000
DTEND;TZID=Europe/Berlin:20221118T173000
DTSTAMP:20260929T013720
CREATED:20220811T164159Z
LAST-MODIFIED:20221103T122702Z
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SUMMARY:3rd EUFEMEDs Innovation Club Webinar
DESCRIPTION:Reporting obligations under the Clinical trial Regulation: SUSARS\, Serious Breaches\, Summary of Trial Results and Lay Summary of trial results via CTIS \n\n\n\n	INFORMATION \n2023 – When the CTR will be in force for all – Let’s be prepared \nEUFEMED’s Innovation Club is inviting you to the second Webinar on prepara-tion for the new regulatory environment under the Clinical Trial Regulation \nUnder the Clinical Trial Regulation the clinical trial authorisation application has to occur in a new process: a “Single Dossier” has to be submitted to the “Single Portal” of CTIS (EU Clinical Trial Information System). Sponsors have to respond within a few days to deficiencies in the validation process and to “Requests for Further Information”. Access to CTIS\, the dossier preparation and submission\, and the decision making process on further information to be submitted require a very detailed planning and agreement between sponsor and clinical trial unit/CRO on responsibilities and oversight. In this webinar we will discuss strategies and first experiences on efficient collaboration between international sponsor organisati-ons and early phase service providers. \nA detailed program will follow soon. \nATTENDANCE FEES (excl. VAT): \n\nMember ticket: € 30.00\nNon-member ticket: € 60.00\n\nMember ticets are available for members of: Association of Human Pharmacology in the Pharmaceutical Industry (AHPPI - UK)\, Healixia (Belgium)\, Association Française de Pharmacologie Translationnelle (AFPT – France)\, Association for Ap-plied Human Pharmacology (AGAH - Germany)\, Associatie van Contract Research Organisaties in Nederland (ACRON - Netherlands) \n  \n\n\n\n\n	PROGRAM UND ANMELDUNG \nhttps://courses.2mpact.be/eufemed-2022-1609 \n  \n\n\n\n\n	KONTAKT \nVerantwortlich für das Programm und die Durchführung \nEUFEMED\nRue de l’industrie 4\n1000 Brussels\nBELGIUM \ninfo@eufemed.eu\nwww.eufemed.eu \n 
URL:https://dev.agah.eu/event/3rd-eufemeds-innovation-club-webinar-2/
LOCATION:Webinar
CATEGORIES:Termine,Workshops
ORGANIZER;CN="EUFEMED":MAILTO:info@eufemed.eu
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