European Regulatory Procedures - Comprehensive Overview of EMA and National Requirements and other Agencies 2017 is a conference that covers topics such as:
- 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
European Regulatory Procedures - Comprehensive Overview of EMA and National Requirements and other Agencies 2017 brings together:
- 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
