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Tuesday, 22 June 2010
By streamlining the qualification process for biomarkers, coordinated
protocols recently implemented at the different regulatory agencies can
facilitate progress and provide impetus to novel biomarker discovery
and validation.
Since the sequencing of the human genome was first announced in 2000,
regulatory agencies in the United States (The Food and Drug
Administration; FDA, Rockville, MD), Europe (European Medicines Agency,
EMEA; London) and Japan (the Pharmaceuticals and Medical Devices
Agency, PMDA; Tokyo) anticipated the potential impact of this new
knowledge on drug development and together initiated a series of
fact-finding international conferences with the objective of obtaining
input from the pharmaceutical industry and other stakeholders. Several
initiatives have since been developed to address the need for sharing
knowledge and risk associated with the use of the new genomic
methodologies in drug research and development.
European Medicines Agency implements internal reorganisation
Tuesday, 13 October 2009
The European Medicines Agency has begun implementing a series of changes to its internal organisation aimed at improving the functioning of the Agency and the way in which it delivers its core tasks. The changes will be introduced gradually from September to December 2009.
EU to offer 'incentives' for alternative antibiotic research
Monday, 12 October 2009
The European Union is stepping up the fight against hospital bugs amid fears that antibiotic-resistant bacteria could spark a plague of infectious disease which will paralyse healthcare systems.
NGOs want medicines removed from EU industry policy
Wednesday, 24 June 2009
A broad coalition of NGOs is urging EU leaders to take responsibility for pharmaceutical policy out of the European Commission's industry section and hand it to its health and consumer affairs department. The call comes as heads of government meet in Brussels today (18 June) ahead of a reorganisation of the EU executive and the possible implementation of the Lisbon Treaty.
EU leaders commit to more action on Rare Diseases
Wednesday, 24 June 2009
On June 9, Health Ministers from the 27 EU Member States unanimously signed up to a series of political commitments on behalf of Europe’s rare disease patients, by adopting a Council Recommendation on a European Action in the Field of Rare Diseases1. This means that Member States have committed to creating a rare disease action plan at national level and to cooperating at a European level on this important and unmet public health priority.
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