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.