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Peter O'Donnell is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium.

Articles

Inaugural group of members added to EMA’s new data network focused on RWE.

New guidance to drill down on more specifics in hopes of harnessing the growth of these types of studies. 


Jill Wechsler is ACT's Washington Correspondent

Following closely contested election, approval of FDA bills most likely tabled until new year.

Rare disease stakeholders speak out ahead of anticipated EU changes.

Director, Quality & Compliance, Diligent Health Solutions

Global Chief Operating Officer, Diligent Health Solutions

Virtual audits proving to be beneficial post-COVID despite continuing challenges.

Potential drug removal spotlights latest debate over the expedited pathway.

Smoothing path to CTIS compliance will be key in overall effort to transform clinical trials in Europe.

New EU clinical trial regulation places heavy importance on patient-submitted documents.

Sheri Kuss, clinical quality group lead at Pfizer, discusses the new "culture of quality" in clinical trials.

The hope is to build a formal framework for using digital health technology in clinical trials in Europe and beyond.