52 - European and International Regulatory Perspectives (S21E3)

Explore the European Medicines Agency (EMA) and the ways this group works with international bodies to regulate clinical trials. This podcast episode discusses the ICH harmonization, and how this integrates with global standards, while taking into account the regional differences.

Explore ICH's E6R3 draft guideline and ICH's Q series which provides guidance on how to achieve consistent quality in pharmaceutical manufacturing globally. It also covers what regulators in the European Union use. This podcast explores how they navigate differing regulations and how it affects the creation of multinational clinical studies.