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

  1. beatriz-perez-moya-XN4T2PVUUgk-unsplash.jpg
    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.

  2. scott-graham-5fNmWej4tAA-unsplash.jpg
    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…).

  3. beatriz-perez-moya-XN4T2PVUUgk-unsplash.jpg
    18 October '22

    Webinar: The sources of life sciences regulations - part II: Medicinal products

    Online

    This session is the second part of a two-part training course on the “Sources of life sciences regulation”. It serves to provide participants with a high-level overview of the rules and regulations applicable to medicinal products for human use 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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News

  1. June 23, 2022

    The FAMHP launches the Medicinal Product Management database: updating data in existing medicinal product databases temporarily not possible

    On 4th of July 2022, the FAMHP launches the Medicinal Product Management database, a new internal database for medicinal products. Due to the launch, it will be temporarily impossible to update the data in the existing medicinal product databases.

    Source: FAMHP

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  2. June 23, 2022

    Flash VIG-news: Nifuroxazide: important information on the use in pregnancy and lactation, mutagenicity and carcinogenicity

    Uit voorzorg mag nifuroxazide niet worden toegediend tijdens de zwangerschap en de borstvoeding.  Bij vrouwen die zwanger kunnen worden, mag nifuroxazide alleen worden gebruikt als zij effectieve anticonceptie gebruiken.

    Par mesure de précaution, le nifuroxazide ne doit pas être administré pendant la grossesse et l'allaitement. Le nifuroxazide ne doit être utilisé chez les femmes en âge de procréer que si elles utilisent une contraception efficace. 

    Source: FAMHP

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  3. June 23, 2022

    Sleeping pills: survey by the FAMHP shows that more than a third of patients show signs of dependence

    Meer dan achthonderd patiënten hebben deelgenomen aan een online bevraging van het FAGG over het gebruik van benzodiazepines en aanverwante geneesmiddelen bij slaapstoornissen. De bevraging toont aan dat de meeste patiënten deze geneesmiddelen te lang gebruiken. Meer dan een derde vertoont psychologische tekenen van afhankelijkheid. 

    Plus de huit cent patients ont participé à une enquête en ligne de l’AFMPS sur la consommation de benzodiazépines et de médicaments apparentés utilisés dans le cadre des troubles du sommeil. L’enquête montre que la plupart des patients consomment ces médicaments pendant trop longtemps. Plus d’un patient sur trois montre des signes de dépendance psychologique. 

    Source: FAMHP

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