Réglementaire - Sciences de la Vie

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• Busting the Blockchain myth in healthcare

  Conférence

  Date de l’évènement: 23 May 2018

  One HealthTech and Simmons & Simmons present an evening of fresh, thought-provoking discussion on blockchain in healthcare.

• Orphan drug exclusivity: case law update

  Article

  Envoyé: 19 April 2018

  In this article, we recap on the earlier Teva v EMA decision and summarise the recent outcome in Shire v EMA. We have also included relevant parts of the Regulation 141/2000 on Orphan Medicinal Products in the Annex hereto.

• Sunshine Act: Last-minute checklist ahead of the deadline

  Article

  Envoyé: 13 April 2018

  The final date to upload transparency reports on www.betransparent.be is Thursday 31 May 2018. Ahead of this final date, we prepared a checklist with practical action points to consider ahead of the deadline.

• Artificial Intelligence: the key French priority

  Article

  Envoyé: 03 April 2018

  The French report on artificial intelligence (AI) was finally released this Thursday, 29 March 2018. The mission who issued the report (also named “Villani’s” report after its leader, Cédric Villani, French Member of the National Assembly, Fields medal laureate 2010), was commissioned by the French Government in September 2017 to consider the French strategy for artificial intelligence (AI).

• New EU proposal for a regulation on health technology assessment (HTA) - Analysis

  Article

  Envoyé: 16 March 2018

  An HTA Proposal from the European Commission represents a new step toward harmonized market access for health technologies in the EU.

• Dispositifs médicaux: Nouvelle règlementation d'autocontrôle

  Article

  Envoyé: 09 March 2018

  Le législateur belge a récemment encadré l’installation, la maintenance et le retrait de dispositifs médicaux dans le cadre de leur utilisation au domicile du patient.

• Publishers and operators of mobile health and well being apps: French competition authority and other authorities in Europe are watching you

  Article

  Envoyé: 01 March 2018

  The rise of Information Technologies and Telecommunications and particularly the Internet of Things allows the implementation of connected tools and services.

• New European thresholds for public procurement procedures

  Article

  Envoyé: 19 January 2018

  T​he EC published new European thresholds for public procurement procedures. In Belgium, these thresholds have been implemented by a Ministerial Decree of 21 December 2017 and are applicable as of 01 January 2018.

• Relation entre l'industrie et les médecins: Les contrats de consultance

  Article

  Envoyé: 19 January 2018

  Pourquoi les sociétés pharmaceutiques et de dispositifs médicaux faisant appel aux services d’un médecin soumettent-elles souvent un projet de contrat écrit d’une certaine ampleur?

• The French investment plan for 2018-2022 and Digital Health

  Article

  Envoyé: 09 January 2018

  In the December 2017 issue of Digital Health Legal, Christophe Fichet, Benjamin Znaty and Edwige Lataste discuss the proposals put forward in the Pisani-Ferry report, which provide valuable insight into what the digital health roadmap in France might look like for the years ahead.

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