European Regulatory Procedures - Comprehensive Overview of EMA and National Requirements and other Agencies 2017

Topics

• Challenges to global submissions management presented by EU versus US key differences
• What is EMA and the overall process with CP, MRP, DCP and other interactions with agencies?
• Challenges and pain points to the global submissions management process and making critical regulatory decisions based on EU versus US differences
• The EU legislative environment and the key EU Directives and Regulations relating to human medicines and for strategic regulatory intelligence decision-making
• How to apply the different types of procedures for authorization
• Navigating the regulatory process through EMA regulations and inspection guidelines regarding submissions
• If "full/usual" authorization not possible, several options exist

Who should Attend

• Clinical Project Managers
• Clinical Research Associates
• Clinical Investigators and Clinical Research Coordinators
• Regulatory Affairs Professionals
• Regulatory Affairs Specialist
• Regulatory Affairs Management
• Compliance Specialist
• Auditors
• Quality Assurance Management
• Clinical Affairs
• Consultants