1. August 17, 2021

    Coronavirus: biweekly update of COVID-19 vaccines dated 29 July 2021

    Coronavirus: tweewekelijks overzicht bijwerkingen COVID-19-vaccins van 29 juli 2021

    Coronavirus : aperçu bimensuel des effets indésirables des vaccins contre la COVID-19 du 29 juillet 2021

    Source: FAMHP

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  2. August 17, 2021

    Limited availability of RoActemra (Roche): recommendations for (hospital) pharmacists, general practitioners and physician specialists.

    The stock of RoActemra, a medicinal product used for certain rheumatological and haematological disorders, is currently limited worldwide. The Federal Agency for Medicines and Health Products (FAMHP) therefore issues recommendations.

    Source: FAMHP

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  3. August 17, 2021

    Give your opinion on a genetically modified medicine to treat dementia

    The FPS Public Health and FAMHP would like to invite you to take part in the public consultation on a clinical trial testing the genetically modified medicine PR006A to treat frontotemporal dementia with progranulin mutations (FTD-GRN).

    Source: FAMHP

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  4. August 17, 2021

    Updated guidance for submission of clinical trial applications, substantial amendment notifications and end of trial declarations to the FAMHP

    A new version of the guidance for submission of clinical trial applications, substantial amendment notifications and end of trial declarations to the FAMHP is available.

    Source: FAMHP

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  5. August 17, 2021

    Safety notifications for medical devices from manufacturer Philips: CPAP, BiPAP and ventilation equipment

    Veiligheidsmeldingen voor medische hulpmiddelen van fabrikant Philips: CPAP, BiPAP en beademingstoestellen

    Informations de sécurité pour des dispositifs médicaux du fabricant Philips : CPAP, BiPAP et respirateurs

    Source: FAMHP

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  6. August 17, 2021

    End of submissions for initial CTR pilot files on 14 October 2021

    The pilot project for the new Clinical Trial Regulation (CTR) will end when the CTR Regulation enters into force. All initial dossiers under the CTR pilot procedure must be submitted by 14 October 2021.

    Source: FAMHP

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  7. August 17, 2021

    Floods in Belgium: Continuity of access to medicines guaranteed in the affected areas

    Overstromingen in België: continuïteit van de toegang tot geneesmiddelen gewaarborgd in de getroffen gebieden

    Inondations en Belgique : la continuité de l’accès aux médicaments assurée dans les zones sinistrées

    Source: FAMHP

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  8. August 17, 2021

    Unavailability of Visudyne 15 mg (powder for solution for infusion) : recommendations for (hospital) pharmacists and physicians-specialists

    The medicinal product Visudyne 15 mg, used in ophthalmology, has been unavailable in Belgium since 30 May 2020. The FAMHP is therefore making recommendations.

    Source: FAMHP

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  9. August 2, 2021

    Call for applications to participate in the IFAPP working groups

    With the election of a new Board of Officers (BoO) with new Standing Officers as Chairs of the Working Groups (WGs) we encourage you to apply for active membership in on of the following WGs:

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  10. July 20, 2021

    Save the date: An EQ-5D-5L value set for Belgium – How to value health-related quality of life?

    Source: KCE

    Een Belgische waardenset voor de EQ-5D-5L – hoe gezondheidsgerelateerde levenskwaliteit waarderen?

    Une matrice de valorisation belge pour l’EQ-5D-5L – Comment évaluer la qualité de vie liée à la santé ?

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