"The Clinical Trials Directive 2001/20/EC aims to simplify and harmonize the rules and administrative provisions governing clinical trials in the EU by establishing a common procedure and creating conditions that will help regulatory authorities coordinate such trials. Because of the significant differences in interpretation of rules and implementation of the directive across EU member states, the European Commission is reviewing the directive. Clinical development of medicinal products (including those derived from novel technologies) and multicenter trials on a pan-European basis will be enhanced through better harmonization of technical standards and application procedures and timelines (perhaps through a regulation/mutual recognition of decisions, etc.)."

Objective1: Describe the system for promoting the conduct of clinical trials within Europe.

Objective2: Present potential recommendations for the future.

Objective3: Explore opportunities for ensuring transatlantic synergies and for removing unnecessary bureaucracy.