This innovative program prepares the student for working in the highly regulated medical industry in the specialized area of Drug Safety or Pharmacovigilance.
Upon completion of the Drug Safety and Pharmacovigilance certificate program, students will be able to:
- Be knowledgeable in laws, regulations, and guidelines related to drug safety and pharmacovigilance principles
- Outline the product development process for medical products
- Locate information necessary in their role as drug safety and pharmacovigilance professionals
- Describe the pre-approval and approval requirements for the safety of new products, including the maintenance of those products after marketing through pharmacovigilance systems
- Be familiar with the complex interaction between regulatory requirements and development processes for new products.
- Apply established principles of the submission process that regulatory authorities use to evaluate new medical product applications Be familiar with safety signal monitoring and detection technologies