Global Regulatory Strategy for Pharmaceuticals

Understanding global demands from the perspective of regulators, patients, healthcare providers and payors is a critical necessity when creating a global regulatory strategy that will support the development and marketing of a drug product. The continued success of the International Conference on Harmonization (ICH) in defining regulatory standards acceptable to numerous global health authorities has moved the concept of global, simultaneous marketing applications for drug products from a wish to an ethical and business reality.

This course provides a basic understanding of the challenges and goals confronting a regulatory professional when defining a global regulatory strategy. It provides an overview 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 also includes a description of the regulatory “tools” at the disposal of the regulatory professional and discusses reimbursement considerations and how they may affect both a global development strategy and regulatory strategy. Finally, the course provides insight into the role of the regulatory professional in global, cross-functional strategy teams and provides guidance for effective interfacing with team members. Collectively, this knowledge is critical to creating a global regulatory strategy to get your product into major markets.

This course now includes an interactive simulation tool! Using immersive technology, you will explore your decision-making process for choosing appropriate regulatory strategies during drug development and marketing authorization preparation, submission and approval and watch as consequences unfold.

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
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

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.

Please note:
This course is available for single purchase or as part of the Regulatory Affairs Certificate Program, including the Pharmaceuticals and Dual program options. Single course purchase provides three-month access; the Pharmaceuticals program option provides six-month access; and the Dual program option provides 12-month access.

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