Online CourseOnline Course Pharmaceutical Certificate ElectivePharmaceutical Certificate Elective

Global Regulatory Strategy for Pharmaceuticals [4.0 RAC]

4.0 RAC Credits Member: $465.00 Nonmember: $640.00
Global Regulatory Strategy for Pharmaceuticals [4.0 RAC]
Understanding global demands from the perspective of regulators, patients, healthcare providers and payors is a necessity when creating a global regulatory strategy to support the development and marketing of a drug product. The concept of global, simultaneous marketing applications has moved from a wish to an ethical and business reality due to the continued success of how the International Council for Harmonization (ICH) defines regulatory standards that are acceptable to numerous global health authorities.

This course provides a basic understanding of the challenges and goals confronting a regulatory professional when defining a global regulatory strategy. It provides an examination of the regulatory considerations in the major regions of the world where marketing applications are pursued and compares the application requirements in these regions. It describes regulatory tools, discusses reimbursement considerations and how they may affect strategy development, from both a global and regulatory perspective. Finally, the course provides insight into the role of the regulatory professional in global, cross-functional strategy teams and guidance for effective interfacing with team members. Collectively, this knowledge is critical to creating a global regulatory strategy to successfully launch your product into major markets.

At a Glance
  • Target Audience: The course will provide a foundation for those entering the area of global drug development, and discussion points and considerations for those looking to further develop their knowledge.
  • Learning Level: Basic, Intermediate
  • Total Length of Course: 4 Hours
  • RAC Points: 4

Learning Objectives

Upon completion of this course, participants should be able to:
  • Define global regulatory strategy and explain how such a strategy may be applied to support multi-regional marketing applications
  • 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

Lesson Titles
  • Lesson 1: Overview of Drug Development During the Past Decade
  • Lesson 2: Elements of Regulatory Strategy
  • Lesson 3: Understanding the Requirements of a Global Strategy team

Enrollment Period: 12 months
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