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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 the final draft3 for what the changes will be. The amazing thing about this second revision (the first constituted minor textual changes, no content changes) is that the outlined responsibilities in the original version have not changed! R2 only adds to the original text. It doesn’t change anything from what we already know and do. It mainly specifies some responsibilities and adds today’s world to a 20 year old guideline.

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  1. http://fourplusmore.com/2016/08/16/changes-ich/
  2. http://www.ich.org/fileadmin/Public_Web_Site/News_room/B-Press_Releases/ICH_GCG_Press_Releases/Press_Release_Osaka_10Nov2016_Final.pdf
  3. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R2__Addendum_Step2.pdf

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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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 in the past 20 years and not without controversy. So where does ICH, and for that matter some of their official parties, stand on the current DoH?

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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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