EMA news in brief

Published: 23-Jun-2010
Regulatory

EMA re-elects Pat O\'Mahony as chairman of the management board


The European Medicines Agency’s (EMA) management board has re-elected Pat O’Mahony, chief executive of the Irish Medicines Board, as chair for a second three-year mandate.


EMA has released a guideline on the quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells.


The agency has released recommendations on the current use and future needs of radiopharmaceuticals labelled with radionuclides produced in reactors.


It has also published a paper on revising advice on the clinical investigation of medicines for the treatment of cardiac failure


And a co-operative working arrangement has been agreed by EMA and the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA). Meanwhile, the European Commission has released draft revised guidance on the collection, verification and presentation of adverse reaction reports arising from clinical trials on medicinal products.
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Cloud labelling and serialisation: the new frontline of traceability in drug delivery

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Novo Nordisk’s oral semaglutide scores EU approval for cardiovascular benefits

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New NICE thresholds: good news for rare disease drugs but process remains complex

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Balancing innovation and accessibility in amino acid testing

Butterworth Laboratories expands analytical capabilities to support compliance with Ph. Eur. standards
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Manufacturing

Quality management during manufacturing changes: part I

Change is a universal constant and continues to accelerate in the realms of pharmaceutical, medical device and in-vitro diagnostic manufacturers who face ever-increasing pressure to optimise costs while maintaining high product quality and patient safety standards
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