Overview: This course covers the newly proposed requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Regulation 536/2014 (for Drugs, Biologics & Combination Products). The course also covers recent updates on EU-GCP associated with the Directive, the highlights of the new EU Pharmacovigilance Directive, as it relates to studies and helpful tips into working with the European regulators.Learning Objectives / Key Topics: Attendees will leave the Course clearly understanding the New Processes and Requirements for EU Sponsors of Clinical Trials as the New Regulation is published, rolled-out and implemented by the Member States, the European Medicines Agency and the European Commission. In addition, this Course has been updated to provide participants with competitive insight into: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 updatesNew EUCT Regulation vs. FDA RegulationsAreas Covered in the Session:Overview of the EU and the EU Regulatory StructureMarketing Authorization Options in the EU and Linkage to Conducting Clinical StudiesOverview of the European Union Clinical Trial Regulation 536/2014Pertinent, Critical Articles of Regulation 536/2014Processes and TimelinesWho Will Benefit:Clinical Operations StaffProject Team MembersQuality Assurance, Monitors, CRAsRegulatory AffairsInvestigators & Site Study StaffClinical Trial SupplyCROs, Consultants, Insurers