Book
About The Book
Global Regulatory Systems: Strategic Primer
A Practical Guide to Global Biopharmaceutical RegulationGlobal Regulatory Systems: Strategic Primer is a comprehensive, practitioner-focused guide to navigating the regulatory landscape of biopharmaceutical development and registration.Covering major markets including the United States, European Union, Japan, Australia, Canada, and emerging global markets, the book follows the product lifecycle from discovery and clinical development through marketing approval and post-approval requirements.At its core is the Global Regulatory Strategy (GRS) framework—a structured approach for developing regulatory plans that are science-driven, commercially aligned, and globally coordinated.
Ideal for: Regulatory affairs professionals, clinical development teams, pharmaceutical professionals, and graduate students.
ABCs of Leadership: Leadership Guiding Principles
Simple Principles. Practical Leadership. Meaningful Impact.ABCs of Leadership is an accessible guide to the qualities, behaviors, and principles that shape effective leaders—and followers.
Organized around the letters of the alphabet, the book makes leadership concepts easy to understand, remember, and apply in everyday life. Through practical examples, real-life vignettes, and inspiring quotes, Dr. Henrietta Ukwu explores the values, ethics, and behaviors that help individuals grow and lead with purpose.
At its heart is a simple message: everyone has the potential to become a leader. Whether at home, in the workplace, or in the community, these principles can help build stronger relationships, develop confident leaders, and create high-performing, engaged, and trust-based teams.
