Medical and clinical affairs professionals play critical roles throughout the lifecycle of pharmaceuticals, medical devices, biologics, and gene therapy. These professionals provide expertise in research and development, product approval and commercialization, clinical trials, manufacturing, labeling and advertising, and post-market surveillance. Pharmacists trained in these areas can combine their expertise in medications and pharmacy practice with clinical trial management, and regulatory affairs knowledge and skills to enhance the development and commercialization of healthcare products. The MCA certificate program will provide student pharmacists with the skills to provide strategic, tactical, and operational direction within medical affairs to expedite the development and delivery of safe and effective healthcare products.

Suggested Topics:

  • US Food and Drug law
  • Medical Device regulatory affairs
  • Biologics Regulatory affairs
  • Drug Regulatory affairs
  • Biopharmaceuticals Quality Assurance and Control
  • Clinical Trials Design, Conduct, & Strategies
  • One of the following:
    • Medical Device Development and Market Release or
    • Marketing Assessment or
    • Risk Management Tools and Techniques