The parallel QbD (Quality by Design) application review program by the US FDA and EMA is slowly revealing the differences between the two agencies but will never result in identical assessments or outcomes, experts said.
Apparently some folks at DIA weren't discussing 'cloud-based' solutions this year but, as Outsourcing-pharma.com didn't find them, here's the news from those who are adding a little cumulonimbus to their blue-sky thinking.
In a momentous first for both countries, regulatory officials from China and Taiwan sat down at the same table on Tuesday and discussed their relatively similar ideas around the regulation of drug approvals.
Outsourcing-Pharma has come to Boston, US for DIA 2013. Best promotion we've seen so far is Medidata Solutions' tie up with the Michael J. Fox Foundation. Go get a photo with a time machine and Medidata will donate in your name.