CPD Courses
How to Gain and Maintain Approval for Clinical Research Under the EU Clinical Trials Directive
Online Course • grapl
About the CPD course
To conduct a clinical trial in the European Economic Area under the Clinical Trials Directive the sponsor must apply for authorisation from the national competent authority (medicines regulator); and favourable opinion must be obtained from a research ethics committee; in each member state in which the trial is to take place. This module sets out the requirements for successful compilation; submission and maintenance of the applications. During the first year of transition to the Clinical Trials Regulation; sponsors have the option of applying for approval under the Directive; and they can continue trials under that regime until 31 January 2025.
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grapl
grapl is a UK based digital learning and development specialist, authoring and designing Zenosis® courses to provide an extensive eLearning library for the pharmaceutical, biotech and medicinal products sector. This learning can be delivered via the customers LMS, the grapl LMS or its social, knowledge and collaborative CloudRooms platform. Continuously updated to reflect regulatory changes, Zenosis® courses are trusted to educate their people by some of the worlds leading companies.
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