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X-WR-CALNAME:NVFG | Nederlandse Vereniging voor Farmaceutische Geneeskunde
X-ORIGINAL-URL:https://www.nvfg.nl
X-WR-CALDESC:Evenementen voor NVFG | Nederlandse Vereniging voor Farmaceutische Geneeskunde
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DTSTART:20220327T010000
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DTSTART:20221030T010000
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DTSTART;VALUE=DATE:20221108
DTEND;VALUE=DATE:20221109
DTSTAMP:20260501T184950
CREATED:20220713T123334Z
LAST-MODIFIED:20221018T195938Z
UID:5035-1667865600-1667951999@www.nvfg.nl
SUMMARY:NVFG RegNed Verdiepingscursus
DESCRIPTION:  \nCourse Orphan Medicinal Products  \n8 November 2022 \nWant to know more about the clinical and regulatory framework of Orphan Medicinal Products? Sign up for the in depth RegNed course on this topic to learn all about the investigators’\, applicants’ and regulators’ perspective. In this interactive course the opportunities\, challenges\, regulations and regulatory procedures for bringing Orphan Medicinal Products to the market will be addressed. \nThis course is organised by RegNed\, a division of NVFG. \n  \nCourse content \nThe aim of the course is to introduce participants to Orphan Medicinal Products and the way these products are investigated\, assessed and approved in the EU. The unique features of Orphan Medicinal Products versus “regular” medicinal product will be taken into account. \n  \nThe following topics will be addressed during this one day training: \n\nUnderstanding of orphan indications\, regulatory definitions and incentives\nOrphan drug designation (ODD) with focus on the EU regulations and procedures\nChallenges for development and clinical studies in rare diseases\nMarketing authorization application requirements\nConflicting interests: business\, patient\, regulatory\, reimbursement\nUse of registries and Real World Evidence\nEMA and Dutch registry initiatives\nCase studies\n\n  \nParticipants profile \nWe welcome RA professionals who are interested in Orphan Medicinal Products and who would like to broaden their knowledge. General basic RA knowledge rather than experience in rare diseases /Orphans is expected. \n  \nPractical information \n\nDate: 8 November (Tuesday)\, 9:00h to 17:00h\nLocation: Postillion Hotel\, Bunnik\nFee: € 300\,- (excl. VAT) for NVFG members\, € 450\,- (excl. VAT) for non-members\nMaximum of 30 participants: register now!\n\n  \n \nFor a more detailed description\, please click here
URL:https://www.nvfg.nl/evenement/nvfg-regned-verdiepingscursus/
CATEGORIES:RegNed
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