Global Regulatory Strategy and Planning Process

This course discusses creating the strategy and planning documents that help companies align the development of new products with the regulatory submission process for those products. Along with the regulatory plan, a company’s regulatory strategy describes the overall regulatory approach and the specific tactical steps required to meet regulatory objectives for the product. Topics in this course include: Purpose, Strategy Elements, and Plan Elements. After completing this course, learners will be able to identify the elements of a regulatory strategy and plan that can meet your company’s development needs while meeting regulatory submission requirements for a variety of regulatory environments.

After this course learners will be able to identify the elements of a regulatory strategy and plan that can meet your company’s development needs while meeting regulatory submission requirements for a variety of regulatory environments.