What are the requirements for the legal representative of a non EU-sponsor in view of article 74 of

New draft of the guidance documents applying to clinical trials has been issued in July 2020 by EU. If the sponsor is not established in the EU a legal representative of the sponsor has to be established in the EU If the sponsor is the same for several different trials, it is acceptable (but not obligatory) to have one central legal representative in EU for all non-EU sponsored trials, as long as the responsibilities provided for by the regulation can be effectively performed It is also acceptable to use an established company as a legal representative. The applicant for the application to the Member State (competent authority and the Ethics Committee) might be different from the legal repre

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