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API GMP Requirements Update
In order to ensure that APIs meet the requirements for quality and purity that they purport or are represented to possess, the Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (Q7) was developed by the International... more »
Apr 29, 2013 in Regulatory Affairs Blog
EPM’s First Visit to TechnoPharm and POWTECH
The EPM team has just returned from the TechnoPharm and POWTECH show in Nuremberg. It was our first time at the event and in Bavaria’s second largest city, which dates back to the 11th century and is famous for the post-WWII Nuremberg trials. more »
Apr 26, 2013 in Editor's Blog
I Holland's R&D Manager Gives Lowdown on Anti-Sticking Project
In January 2012, Holland and the University of Nottingham’s School of Pharmacy launched the two-year TSAR (Tabletting Science Anti-Stick Research) project to investigate and solve the most common tabletting issue of formulation ‘sticking’ to the.. more »
Apr 11, 2013 in Editor's Blog
Biosimilars Sector from EU and US Perspectives
Biosimilar medicines, one of the fastest growing sectors of the industry, constitute a major share of pharmaceutical expenditure in the EU, the US and globally. From a regulatory perspective, they are a new paradigm in drug development, similarly... more »
Mar 26, 2013 by Paolo Biffignandi in Regulatory Affairs Blog
Fancy Joining EPM's EAB?
I'm always keen to hear from individuals interested in joining the magazine's Editorial Advisory Board (EAB). more »
Mar 20, 2013 in Editor's Blog