...and much more [BE/BA News]
yes, and there's no doubt there's going to be lots of interesting news in the coming years.
There's a WP dedicated to M&S which is picking up speed (there wouldn't be one if the general attitude towards M&S was entirely negative, would there?!?), and the OIP guideline from 2009 is also under revision which will create obstacles for some and pave ways forward for others.
And I was asked yesterday by an agency employee if we need a dedicated data integrity guideline and/or WP. I think this question was posed in view of the recent horror stories about BE CROs.
if (3) 4
"(...) targeted cancer therapies will benefit fewer than 2 percent of the cancer patients they’re aimed at. That reality is often lost on consumers, who are being fed a steady diet of winning anecdotes about miracle cures." New York Times (ed.), June 9, 2018.