The flexibility and incompatibility of ICH Q12 guidelines with current EU legislations raise complications. As the world’s economy is increasingly threatened by new barriers to trade, the ...

The internationally harmonized guideline for a risk-based approach on assessing and controlling elemental impurities in drug products entered the final implementation phase. ICH Q3D(R1) Guideline for ...

Pharma Lessons is pleased to announce the launch of its newly revised Good Clinical Practice (GCP) online training course, now fully aligned with the latest ICH GCP E6(R3) guidance.This update ...

At ICH’s November 2016 meeting, the council announced new members and new guidelines. The International Council for Harmonization (ICH) announced it was developing a new guideline on the collection of ...

Those who have come to believe that "Johnson & Johnson" and "quality" are mutually exclusive terms may be surprised to learn that the healthcare giant's director for quality and compliance presented ...