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
    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.

  2. debby-hudson-IjQdCrknYXI-unsplash.jpg
    17 November '22

    Introduction to Regulatory Affairs 2022

    Brussel

    The course is addressed to people new to regulatory affairs who want to acquire a comprehensive foundation; to regulatory professionals wishing to update their knowledge, and to all collaborators working in close relationship with regulatory affairs and wishing to understand the role of the department.

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    22 November '22

    Healixia workshop on RIP role and RIP legislation

    Affligem

    During this workshop, we will work in small groups, where you can discuss different cases, challenges, bumps in the road, best practices,... with peers. Each group will have a lead who is experienced in the RIP role and RIP legislation.

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News

  1. October 7, 2022

    PRAC October 2022 – New measures for terlipressin-containing medicines and change to product information for combination of medicines with codeine and ibuprofen

    During its October 2022 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has recommended new measures for terlipressin-containing medicines and has also recommended a change to the product information for codeine with ibuprofen combination medicines. The PRAC also discussed direct healthcare professional communications (DHPCs) containing important safety information for terlipressin-containing medicines and Imbruvica.

    Source: FAMHP

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  2. October 7, 2022

    Amended legislation: drug precursors added to list of scheduled substances

    The European Commission's new Delegated Regulation (EU) 2022/1518 adds two drug precursors to the list of scheduled substances. The regulation entered into force on 3 October 2022.

    Source: FAMHP

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  3. October 6, 2022

    IFAPP Today newsletter - October 2022

    Source: IFAPP

    Please find here the link to the IFAPP TODAY newsletter of October 2022.

    Read more

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