FRA: Global Regulatory Strategy for Pharmaceuticals Course + FRA Exam

Understanding global demands from the perspective of regulators, patients, healthcare providers, and payers is a necessity when creating a global regulatory strategy to support the development and marketing of a drug product. The continued success of the International Council for 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 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 also includes a description of the regulatory “tools” at the disposal of the regulatory professional and 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 provides 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.

Global Regulatory Strategy for Pharmaceuticals online course
This course provides a basic understanding of the challenges and goals confronting a regulatory professional when defining a global regulatory strategy.

FRA: Global Regulatory Strategy for Pharmaceuticals Exam
Passing this assessment shows you have gained important regulatory knowledge and will allow you to earn the FRA: Global Regulatory Strategy for Pharmaceuticals Assessment-Based Certificate.
 

Access Period: You have 12 months to take the exam from the time of purchase.