ICH IWG E7published the finalised Q&A Guideline "Studies in Support of Special Populations: Geriatrics". This is an outcome of the ICH 2010 Meeting held in Tallin (Estonia) in June.

The second publication in the new GMP MANUAL series deals with the topic "Validation Procedures" and is now available. It contains all important GMP MANUAL chapters concerning this topic.

Until August 31, 2010 we offer you a  summer discount of 30% for selected products from our GMP MANUAL series. By making use of this offer, you can save up to € 200 or $ 298!

At the beginning of August FDA published the list "Questions and Answers on Current Good Manufacturing Practices, Good Guidance Practices, Level 2 Guidance Holding and Distribution". The document provides information about the recall of human drugs and details about the agency’s authority and manufacturers’ responsibilities.

End of July 2010 FDA and EMA published a common document describing their joint GMP Inspection Pilot Programme.

WHO (World Health Organization) recently published the latest issue of the 957 WHO Technical Report Series concerning information provided by the "WHO Expert Committee on specifications for pharmaceutical preparations". This publication makes available the findings of several international groups of experts that provide WHO with the latest scientific and technical advice.

Asian Markets are becoming increasingly important for manufacturers in Europe and the U.S. The knowledge about the regulations in Asia is a key information for global engaged companies.

The European Commission (EC) started a public consultation on the technical aspects of the revision of the Directive on InVitro Diagnostic (IVD) Medical Devices (98/79/EC).