From Concept to Medicine - A Comprehensive Drug Development Journey

3 - Global Regulatory Frameworks and cGMP (S13E3)


Listen Later

Venture beyond national borders to explore the diverse and interconnected global regulatory landscape that shapes cGMP practices worldwide. This episode compares and contrasts major regulatory agencies, such as the FDA in the United States and the EMA in Europe, highlighting their similarities and differences in expectations. We'll delve into the role of the International Council for Harmonisation (ICH) in striving to create a unified, global framework for GMP, promoting consistency and collaboration across different regions.

Understand how these international standards interrelate and harmonize, ultimately ensuring the safety and quality of pharmaceutical products, regardless of where they are manufactured or consumed. Examine the challenges faced by multinational companies navigating this complex web of regulations and consider how global best practices are integrated into local inspections and compliance strategies. Explore real-world examples, discuss the importance of audits, and highlight the critical role of technology in shaping the future of global GMP compliance.

...more
View all episodesView all episodes
Download on the App Store

From Concept to Medicine - A Comprehensive Drug Development JourneyBy Jim Mitchell

  • 5
  • 5
  • 5
  • 5
  • 5

5

4 ratings


More shows like From Concept to Medicine - A Comprehensive Drug Development Journey

View all
The Daily by The New York Times

The Daily

110,824 Listeners

The Peter Attia Drive by Peter Attia, MD

The Peter Attia Drive

8,007 Listeners

BioCentury This Week by BioCentury

BioCentury This Week

30 Listeners

The BioCentury Show by BioCentury

The BioCentury Show

11 Listeners