Elective Courses by Concentration

Clinical Concentration

  • Clinical Trial Design Operations: Clinical, Regulatory, and Pharmacovigilance (1 credit = 4 units)
  • Medical Affairs and Medical Information (½ credit = 2 units)
  • Project Management (½ credit = 2 units)
  • Special Populations: Target populations, pediatrics, rare & neglected diseases (½ credit = 2 units)
  • Operations: Clinical, Regulatory, Pharmacovigilance and Devices (½ credit = 2 units)

Regulatory Affairs Concentration

  • Regulatory Pathways: US, EU, Japan and Rest of World ((½ credit = 2 units)
  • Quality Assurance Oversight of Pharmaceuticals, Biologics & Medical Devices (½ credit = 2 units)
  • Operations: Clinical, Regulatory, Pharmacovigilance and Devices (½ credit = 2 units)

Safety Concentration

  • Toxicology (½ credit = 2 units)
  • PV Management: Case, Signal, Benefit/Risk (½ credit = 2 units)
  • Pharmacoepidemiology: Special Topics – Registries, Post-Approval Studies, and Large Electronic Databases (½ credit = 2 units)
  • Operations: Clinical, Regulatory, Pharmacovigilance and Devices (½ credit = 2 units)

Manufacturing and Devices Concentration

  • Medical Devices and In vitro Diagnostics (½ credit = 2 units) Quality Risk Management: Principles and Practices (½ credit = 2 units) Quality Assurance Oversight of Pharmaceuticals, Biologics & Medical Devices (½ credit = 2 units) Operations: Clinical, Regulatory, Pharmacovigilance and Devices (½ credit = 2 units)

R&D Management Concentration

  • Project Management (½ credit = 2 units)
  • Portfolio, Partnerships and Alliance Management (½ credit = 2 units)
  • Knowledge Management (½ credit = 2 units)
  • Medical Affairs and Medical Information (½ credit = 2 units)

Business and Policy Concentration

  • Research Bioethics and Business Ethics in the Pharmaceutical Industry (½ credit = 2 units)
  • Pharmacoeconomics, Reimbursement & Patient Access (½ credit = 2 units)
  • Legal Principles and Intellectual Property (½ credit = 2 units)
  • Finance and Valuation (½ credit = 2 units) Portfolio, Partnerships and Alliance Management (½ credit = 2 units) Marketing (½ credit = 2 units)


*In order to be offered, each concentration and course listed above must meet the minimum enrollment level