The European Clinical Trial Directive…Plus…European Filings and Registration Procedures: 2-day In-person Seminar
Learning Objectives: Attendees will leave the Course clearly understanding the requirements under the current Directive. This course is designed to provide an overview of the regulatory environment throughout Europe and will provide training in: -How the EU and individual countries within Europe interact -Which registration procedure to use -How regulations effect product development strategies -Pricing issues – Coordinated filing vs. Individual filing -Understanding the concerns/issues of European Regulatory Personnel -How to negotiate with the regulators -Information necessary for effective submissions -Strategies for streamlining the registration application process for faster approval -The advantages and disadvantages of various registration procedures -How to efficiently initiate trials…..first patient, first visit -How to link the strategy of Country Selection to an ultimate EU Licensing Plan -Efficiently implementing studies via project teams and CROs at the National and multi-state level -How to stay compliant…..What can make the difference in your data passing Regulatory scrutiny -Related area-GCP and PV-reporting updates -EUCTD vs. FDA Regulations For Registration: http://www.complianceonline.com/ecommerce/control/seminar?product_id=80126SEM&channel=limsfinder
