Global Health & International Regulatory Affairs in Clinical Research

3 units

This course provides an applied overview of global health considerations and international regulatory frameworks impacting clinical research. Students will explore diverse regulatory pathways, ethics review structures, global trial design, cross-border logistics, data governance, and the responsibilities of academic and non-traditional sponsors operating internationally. Using real-world case studies, students will gain practical skills to plan, manage, and evaluate multinational research studies across a variety of geopolitical, cultural, and regulatory environments.