The Legal Impact in Europe on Pharmaceutical and Medical Device Companies -

The current crisis mode has triggered legal and commercial issues that affect the pharmaceutical and medical device industry across Europe.

CLINICAL TRIALS NOT RELATED TO COVID-19 -

The European Medicines Agency (EMA), together with the European Commission and the Heads of Medicines Agencies (HMA), on 20 March 2020 published an initial Guidance on the Management of Clinical Trials during the COVID?19 pandemic, followed on 25 March by additional points to consider. Sponsors should question whether or not they need to start a new clinical study or include new study participants in an ongoing study; consider whether the study could be temporarily suspended or its overall duration extended; and determine if the conduct of the study could be modi?ed...