Healixia is the Belgian community of all professionals active along the life cycle of medicines, medical devices, in vitro diagnostics & other health related products. Members are active in research & development (including pre-clinical, early clinical and later phases), medical affairs, safety, regulatory affairs and market access in industry, academia, investigator sites, authorities, regulatory bodies or in consultancy.

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Healixia events

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    13 September '22

    Webinar: The sources of life sciences regulations - part I: Medical devices

    Online

    This first session on the “Sources of life sciences regulation” is intended to provide an overview of the main body of the legislation applicable to the placing on the market or making available of medical devices in the European Union. The session will include a specific part on the Belgian legislation. It will also provide the audience with practical tips on researching applicable laws.

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    20 September '22

    Healixia session on GxP interactions

    Affligem

    Save the date!

    During this session, we will tackle the required departmental (inter)actions for ensuring full GxP compliance. The Marketing Authorization Holder’s responsibilities will be highlighted within the legal framework of the different good practice guidelines (GMP, GDP, GVP…).

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    30 September '22

    Webinar: How to use the IB in de-risking FiH study

    Online

    More information will follow soon!

    Speaker: Prof. Dr. Jan de Hoon (UZ Leuven)

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News

  1. July 28, 2022

    Call for Belgian laboratories to apply to become the European Union reference laboratory for in vitro diagnostic medical devices

    The European Commission has launched a call for laboratories of Member States to apply to become European Union reference laboratories (EURLs) for in vitro diagnostic (IVD) medical devices. The possible designation of such EURLs is provided for in article 100 of the Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).

    Source: FAMHP

    Read more

  2. July 25, 2022

    IFAPP Today newsletter - July-August 2022

    Source: IFAPP

    Please find here the link to the IFAPP TODAY newsletter of July-August 2022.

    Read more

  3. July 25, 2022

    Unavailability of Caprelsa 100 mg 30 film-coated tablets: recommendations for specialist physicians and hospital pharmacists

    Het geneesmiddel Caprelsa 100 mg 30 filmomhulde tabletten, dat wordt gebruikt in de oncologie, zal van 26 juli 2022 tot 9 september 2022 onbeschikbaar zijn in België. Het Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten (FAGG) doet daarom aanbevelingen.

    Le médicament Caprelsa 100 mg 30 comprimés pelliculés, utilisé en oncologie, sera indisponible en Belgique du 26 juillet 2022 au 9 septembre 2022. L'Agence fédérale des médicaments et des produits de santé (AFMPS) émet donc des recommandations.

    Source: FAMHP

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