Workshop on draft guideline on requirements for first-in-man clinical trials for potential high-risk medicinal products Event Regulatory and procedural guidance Add to calendar Google Calendar Apple Calendar Office365 Calendar Outlook Calendar Yahoo Calendar
Date Tuesday, 12 June 2007, All day Location European Medicines Agency, Amsterdam, the Netherlands Documents Agenda - EMEA Workshop on the Guideline for first-in-man clinical trials for potential high-risk medicinal productsReference Number: EMEA/177203/2007 English (EN) (33.56 KB - PDF)First published: 08/06/2007 Last updated: 08/06/2007 View European Medicines Agency workshop on first-in-man clinical trials draft guidelineReference Number: EMEA/262385/2007 English (EN) (33.15 KB - PDF)First published: 18/06/2007 Last updated: 18/06/2007 View Workshop on draft guideline on requirements for first-in-man clinical trials for potential high-risk medicinal productsReference Number: EMEA/213289/2006 English (EN) (45.94 KB - PDF)First published: 03/04/2007 Last updated: 03/04/2007 View TGN1412: What happened? - Suntharalingam & N Panoskaltsis English (EN) (1.91 MB - PDF)First published: 15/06/2007 Last updated: 15/06/2007 View Guideline on requirements for First-in-man clinical trials For potential high-risk Medicinal products - JW van der Laan English (EN) (2.96 MB - PDF)First published: 15/06/2007 Last updated: 15/06/2007 View How to define high-risk medicinal products? - C Schneider English (EN) (1.5 MB - PDF)First published: 15/06/2007 Last updated: 15/06/2007 View Demonstration of Relevance of the Animal Model - B. Silva Lima English (EN) (1.71 MB - PDF)First published: 15/06/2007 Last updated: 15/06/2007 View Calculation of the Minimum Anticipated Biological Effect Level (MABEL) and 1st dose in human - Jennifer Sims English (EN) (448.73 KB - PDF)First published: 15/06/2007 Last updated: 15/06/2007 View Elements of Design of FIM Clinical Trials - Ian Hudson English (EN) (2.17 MB - PDF)First published: 15/06/2007 Last updated: 15/06/2007 View Guidance on applications for potential high risk medicinal product trials - Brian Davis English (EN) (1.61 MB - PDF)First published: 15/06/2007 Last updated: 15/06/2007 View GCP inspections and Phase I (F.I.M.) clinical trials - Pierre Henri Bertoye English (EN) (1.34 MB - PDF)First published: 15/06/2007 Last updated: 15/06/2007 View EMEA/CHMP Workshop on draft guideline on requirements for first-inman clinical trials for potential high-risk medicinal products - T Hammond English (EN) (70.93 KB - PDF)First published: 15/06/2007 Last updated: 15/06/2007 View EMEA FIM Guideline - A Cournot English (EN) (59.25 KB - PDF)First published: 15/06/2007 Last updated: 15/06/2007 View CHMP draft Guideline on requirements for first-in-man clinical trials for potential high-risk medicinal products; Bioindustry Perspective - Christiane Abouzeid English (EN) (71.33 KB - PDF)First published: 15/06/2007 Last updated: 15/06/2007 View Workshop on the guideline for First-in-Man Clinical trials for potential high-risk medicinal products - Overview of comments - Highlights - J-M Vidal English (EN) (1.5 MB - PDF)First published: 15/06/2007 Last updated: 15/06/2007 View Share this page