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COVID-19 presents an unprecedented challenge to the global life sciences industry. Members of our International Life Sciences & Healthcare team, lawyers who have a wealth of hands-on experience and strong ...
Competition rules are aimed at safeguarding healthy competition between companies. For more than half a century the EU and its Member States have vigorously defended effective competition by pursuing and ...
Each Belgian biobank will have to be declared at the Federal Agency for Medicines and Health Products (FAMHP) in order to operate. It also imposes binding content for agreements on the transfer of human biological ...
Last month, the Belgian Parliament voted in favour of a set of measures that are notably meant to clarify the regulatory landscape of the operators active in the manufacturing of Advanced Therapy Medicinal Products ...
Introducing a complete regulatory overhaul, the new medical devices regulations contain many topics which industry and professionals should be aware of.
While there has been a proliferation of mobile health (‘mHealth’) apps on the marketplace, concerns have grown that users and healthcare organisations are unable to access evidence of the quality and reliability of ...
In our newsletter of November 2015, we discussed ongoing litigation in Germany and France concerning the liability of Notified Bodies under the Medical Device Directive following the Poly Implant Prothèse ("PIP”) ...
Through an Act of 22 June 2016 providing for various provisions relating to health, published on 1July 2016 in the Belgian Official Gazette (Staatsblad/Moniteur), several amendments have been brought to the ...
The European Commission released a first draft of what will become mHealth apps assessment guidelines at an open stakeholder meeting the 5th of May...
In its judgment of 10 September 2015 , the Court of Justice of the EU (CJEU) has rendered a decision on a request for a preliminary ruling relating to the obligations under the REACH Regulation for articles ...
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