Features

29 June 2012

Voluntary Harmonization Process for Multinational Clinical Trials in the EU

By Surendra Gokhale, PhD and Marina Gasser-Stracca, PhD

In April 2001, Directive 2001/20/EC (the Clinical Trials Directive) came into force with the objective of harmonizing clinical trial processes and detailing the legal provisions for Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) across the EU. The aim was to increase and standardize the protection afforded to clinical trial participants. This article discusses the CTD and harmonization efforts at work in Europe. [Read More...]

---

15 June 2012

It’s a Small World: Collaboration and Harmonization in an Ever-shrinking World

By Jennifer Loscher, PhD

The increasing globalization of the pharmaceutical world means the old saying, “It’s a small world,” is truer now than ever before. However, although the pharmaceutical industry is now truly global, diversity in regulations and standards remains a difficult challenge for the regulatory authorities and industry. [Read More...]

---