DIA 2013

US FDA-EMA QbD Harmonisation Pilot Progressing Slowly

Dispatches from DIA

US FDA-EMA QbD Harmonisation Pilot Progressing Slowly

By Zachary Brennan

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.

Boston, yesterday

Dispatches from DIA

DIA delegates welcome Cloudy forecast

By Gareth Macdonald

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.

China, Taiwan Begin Shift to Regulatory Convergence

Dispatches from DIA

China, Taiwan Begin Shift to Regulatory Convergence

By Zachary Brennan

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.

Medidata and Fox Foundation team for DIA

update

Backlog to the Future: DIA 2013 in pictures

By Gareth Macdonald

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.

Parexel CEO: Growth Rate Slowing to Manageable Pace

Dispatches from DIA 2013

Parexel CEO: Growth Rate Slowing to Manageable Pace

By Zachary Brennan

Parexel’s growth rate has slowed recently to a pace that the company can more easily keep up with than in years past, CEO Josef von Rickenbach told us at DIA’s annual meeting in Boston on Monday. 

Private Equity Snatches PRA for $1.3B

Private Equity Snatches PRA for $1.3B

By Zachary Brennan

Kohlberg Kravis Roberts (KKR) has purchased PRA International for $1.3B, which is about $500M more than previous private equity owner Genstar paid in 2007.

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