Entries by Eric Klaver

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The 6 most important updates to ICH-GCP

It’s official! TODAY, the International Council for Harmonisation (ICH), as is their new name as of October 20151, has published a press release2, declaring that they adopted revision 2 of their E6 guideline, Good Clinical Practice (ICH-GCP or ICH-E6(r2)). As the official final guideline is not yet published on their website, currently we still have to go on […]

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 […]

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 […]

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ICH GCP and the Declaration of Helsinki

A relationship gone south? ICH GCP will have it’s 20th anniversary this year, with the first real update in advanced stages of preparation. It’s aimed at being adopted in November this year1. Where GCP in it’s introduction states that the principles ‘have their origin in the Declaration of Helsinki’, the Declaration (DoH) has evolved significantly […]

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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!