Global Regulatory Strategy for Pharmaceuticals

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.