Pharmaceutical Technology Europe-09-01-2009

Pharmaceutical Technology Europe

The state of validation in the European Union

September 01, 2006

Validation

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Since the formation of the European Union (EU) in 1993, each member state has brought along its own regulatory baggage, namely the standards and regulations that their companies are formally required to comply with. These standards and regulations still apply for any pharmaceutical products a native manufacturer decides to market within their homeland. When the same manufacturer markets its pharmaceutical products to consumers in other EU member states, the regulatory directives of the European Commission and the European Agency for the Evaluation of Medicinal Products (EMEA) apply as well.

Digital Revolution

September 01, 2006

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It's been a while since I last wrote my last editor's comment - a combination, during the last few months, of attending a variety of industry events (as the conference and exhibition season peaked before the summer) and being on holiday. I apologize for the poor excuses, but it's certainly better than saying the dog ate my homework.