FRA - Global Regulatory Strategy

FRA – Global Regulatory Strategy for Medical Devices

• Global Regulatory Strategy for Medical Devices
  • Describe the elements impacting the definition and classification of medical devices globally
  • Determine the points to consider in the development of a global regulatory strategy
  • Define the tools for global regulatory strategy development
  • Recognize sources of regulatory and competitive intelligence
  • Identify the elements of a regulatory plan
  • Apply global regulatory principles to develop a regulatory plan, including STED documents for global registrations

FRA – Global Regulatory Strategy for Pharmaceuticals

• Global Regulatory Strategy for Pharmaceuticals
  • Define global regulatory strategy and explain how such a strategy may be applied to support multi-regional marketing applications
  • Discuss global developments, trends and the future direction of pharmaceutical development strategies
  • Use regulatory “tools,” such as a Global Regulatory Strategic Document (GRSD) and Target Product Profile (TPP), to provide regulatory guidance in cross-functional global strategy teams
  • Understand the role of the regulatory professional in cross-functional global strategy teams
  • Describe the composition and attributes of the International Conference on Harmonization (ICH) that contributes to the global development of pharmaceuticals
  • Understand the cultural and assessment differences between the US and EU that need to be considered when defining a global regulatory strategy
  • Cite recent and ongoing changes within the Japanese health authority and discuss how these changes may affect the timing and content of a global development strategy Understand the basic regulatory requirements in the BRIC-M countries (Brazil, Russia, India, China and Mexico) as part of a global product development and registration program
  • Recognize the relationship between changes in the global regulatory environment and shifts in requirements or understanding of the science essential to supporting a product development program; e.g., the impact of evolving regulatory science in the era of personalized medicines increasing the role of relative effectiveness research and third-party payors