Spring Intro 2023

16/02/2023

Learning Objectives

• Building the Clinical Trial Application • Your role as a Regulatory professional • Strategic planning considerations • VHP EU-CTR • Maintenance of the CTAs • Concluding Remarks

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Building the Clinical Trial Application

• Cover Letter • Application Form (Annex 1) • Proof of Payment

• Letter of Authorisation/Power of Attorney • Investigational Medicinal Product Dossier • Investigator Brochure • Protocol • Clinical trial labels • Informed Consent Form? • Other National Documents?

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