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The recent changes in the requirements for initiating clinical trials within the European Union apply to all clinical trials of medicinal products (including Biologics). This includes all studies held in the European Union (EU), and studies outside the EU which are to be submitted for marketing authorization in Europe. The new EU Regulation (EU No 536/2014) replaces the previous EU Directives (2001/20/EC, 2003/94/EC and 2005/28/EC), with many changes. This has led to confusion from sponsors, Contract Research Organizations (CROs), and sites. Requirements for implementation of and compliance to the EU Regulation have begun: all newly initiated clinical trials must follow these requirements. The question for most of us remains: How do we maintain strict compliance and mitigate risk?
This interactive, 90-minute presentation will provide you with an understanding of key updates, major differences, and common trouble spots. Attending will give you the tools necessary to set a foundation for compliance.
By attending this presentation you will learn…
The objectives of the EU Regulation and why it is replacing the EU Directive
The requirements set forth in the EU Regulation to enable you to prepare yourself for compliance
The new required process for trial registration and applying for a EUDRACT number
The new required procedures for submission of and revision to the Clinical Trial Application
Changes in GMP and GCP
The new role of a “Reporting Member State”
WHO SHOULD ATTEND:
This course will benefit individuals involved in initiating and conducting clinical trials within the European Union or on trials meant to support marketing authorization within the EU. Those working within a Sponsor’s or CRO’s clinical operations and regulatory affairs groups, as well as investigators conducting Investigator Initiated Trials, will find this session extremely beneficial.