Comments on: ICH-GCP E6 R2 Current Updates

By: eebest8 back

eebest8 back — Sat, 11 Aug 2018 13:52:00 +0000

“Wow, great blog article.Really looking forward to read more. Awesome.”

By: runescape bonds

runescape bonds — Sat, 30 Jun 2018 00:19:49 +0000

Highly energetic article, I loved that bit. Will there be a part 2?

By: Brandon

Brandon — Mon, 09 Apr 2018 21:12:48 +0000

Just like a lot of other areas in modern life the average person is far removed from the processes that they directly and indirectly benefit from. This is made all the more complicated by the fact that science behind the disease and/or treatment is typically too complicated for the average person to fully understand. Negativity bias ensures that the term experimentation involving human subjects conjures up some pretty horrific imagery from our not too distant history instead of countless small breakthroughs in latter-days that have allowed grandma to live comfortably into her 80’s. The public is also fairly distrustful of faceless corporations in general, who they feel only exist to make a profit and don’t understand the cost of developing new medications and the fact that pharmacy benefit managers take a hefty cut. I think if the industry wants to increase the public’s engagement in clinical trials they are going to have to invest some time and money into PR so that they can improve their image.

By: Jan Peterson, MS, CCRA, RAC, ACRP-CP

Jan Peterson, MS, CCRA, RAC, ACRP-CP — Sat, 10 Mar 2018 19:39:14 +0000

Regarding the GCP E6(R2) updates, the US FDA has just last week become the fourth regulatory body to recognize it formally since it was published in its final Step 4 form by ICH in November 2016, behind the EMA, Swissmedic, and Health Canada. This revision was not only the biggest change to ICH GCP in 20 years, but the only one to this E6 document. For a write-up on the broader history and likely impact of the E6(R2) update, please see this article from the journal Clinical Researcher from last October: https://www.acrpnet.org/2017/10/09/getting-board-ich-gcp-e6r2-impact-study-quality-operations/