This course introduces the basic structure and contents of the European Union Clinical Trials Directive.  The course also introduces the Member States’ responsibilities concerning the implementation of the Directive, as well as their current status.  Finally, the course discusses the possible effects that the Directive may have on future clinical research.

Topics include:
      ·          The European Union Clinical Trials Directive
      ·          Member States
      ·          Initiation
      ·          IMPs
      ·          Future Prospects

Linda Belmont at DIA