Posts

Name and Organisational Changes at ICH

For 25 years we’ve known ICH to be the International Conference on Harmonisation. That, however, is no longer the case! Since October 2015, ICH is officially called the International Council for Harmonisation. A strategic name change that does not change the abbreviation, however does mark the organisational changes1 that have happened within the organisation.

ICH has, in it’s 25 year existence, developed over 60 Guidelines on Quality, Safety, Efficacy and Multidisciplinary topics, in addition to products including Electronic Standards for the Transfer of Regulatory Information (ESTRI), the Common Technical Document (CTD & eCTD), and the Medical Dictionary for Regulatory Activities (MedDRA).

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Happy 20th anniversary, ICH-GCP!

It’s 20 years ago already that ICH-GCP (E6)1 was formalised. An internationally accepted Good Clinical Practice guideline was born after about 16 years of national and regional GCP guidelines popping up all over the world. And 2016 marks it’s 20th anniversary!

Looking at how we got to ICH-GCP, the establishing of this guideline is almost deviant from how earlier guidelines and regulations came to be. The clinical research industry being mainly disaster driven

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Introducing: Your GCP nerd

Well… it’s 2016! Time to put my writing where my mouth is… So, without further ado: “Introducing: Your GCP Nerd”, Eric Klaver!

For the longest time I’ve referred to myself as the ‘Self-Proclaimed GCP Nerd’… Well, in honesty, course participants started. But I found it to be a compliment worthy of adopting!

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