European Regulatory Watch - BioPharm International

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European Regulatory Watch

Extending the Scope of Pharmacovigilance Comes at a Price

September 1, 2014

As the pharmacovigilance infrastructure becomes more entrenched in Europe, drug manufacturers are beginning to feel the burden of its high cost.

Early Communication with Regulators is Essential for SMEs

January 1, 2014

With SMEs gaining wider recognition as the powerhouse of research and innovation in Europe, regulatory agencies are urging companies to engage with regulators early in the drug-development process.

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