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The research is the key to the fight against Antimicrobial Resistance, but funding against the AMR in Europe is not acceptable because of the magnitude of the heath problem. In this context, in Andalusia (Spain), the PIRASOA Programme has been successfully implemented and developed, integrated into the daily clinical practice. The preliminary outcomes show a reduction of antimicrobial consumption and antimicrobial resistance and an improvement of antimicrobial prescription profile and. However, it ...

EU legislation on human medicines goes back 50 years. Its twofold aim is to safeguard public health without hindering development of the European pharmaceutical industry or trade in medicinal products. The regulatory framework is complex and covers the entire lifecycle of a medicine, from manufacture, to clinical trials, to marketing authorisation, to pharmacovigilance and patient information. Added to that, the principles of good manufacturing, distribution and pharmacovigilance practice contribute ...

This note seeks to provide an initial analysis of the strengths and weaknesses of the European Commission's Impact Assessment on the Revision of the Clinical Trials Directive 2001/20/EC (SWD (2012) 200, SWD (2012) 201 (summary)) accompanying the Commission Proposal for a Regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (COM (2012) 369).