Save the date for

Global Regulatory and Submissions Management in the Pharmaceutical Industry

09th February - 10th February 2017

More about the Venue


Key Topics

  • Regulatory intelligence and its practical impact
  • eCTD and MAA special cases
  • EU Telematic strategy towards 2020
  • CESP, communication and expectations of different stakeholders
  • Global regulatory strategy: Keeping up with the expectations and complexity
  • Harmonization: uniform architecture and centralized master data resource
  • Dengue vaccine registration worldwide case study
  • Operational efficiency: effective data exchange and simplified processes
  • Merck’s strategy for integrating regulatory intelligence in development teams and regional submission strategies
  • Sanofi's strategy for the worldwide registration of the Dengue vaccine
  • IDMP readiness – a case study of a long-established medium-sized company
  • First-hand approaches to how to plan the regulatory strategy that best suits your company
  • A basis for improving communication leading to time-efficient submissions and approvals
Special Features
  • “Set your personal takeaways” sessions
  • People Bingo: ice breaker and networking activity
  • Exclusive case studies
  • Brexit - Panel discussion
  • 10+ interactive sessions
  • 3 roundtable sessions
  • Meet the authorities

Want to know more?

Learn the full details about the event program in the downloadable agenda.

Who You Will Meet

By Department

  • Dossier Management
  • Document Management
  • Data Management
  • Compliance
  • Electronic Publishing/Submissions
  • Global Project Management
  • IT/IS
  • EDMS Post-Approval Marketing
  • Global Regulatory Affairs
  • Translational Medicine/Clinical Pharmacology
  • Regulatory Affairs
  • Submissions
  • Medical Writing
  • Registration office