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[PDF] Top 20 European Medicines Agency. Annual report 2012: Annexes

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European Medicines Agency. Annual report 2012: Annexes

European Medicines Agency. Annual report 2012: Annexes

... Two analyses have been conducted for initial MAAs. The first focuses on eligibility to the centralised procedure. For the purposes of this analysis, multiple applications (i.e. applications which rely on the same dossier ... See full document

132

European Medicines Agency. The European Medicines Agency in 2007. Summary of the thirteenth annual report of the EMEA

European Medicines Agency. The European Medicines Agency in 2007. Summary of the thirteenth annual report of the EMEA

... new medicines to treat a range of diseases and conditions – from cancers to cardiovascular and neurological disorders – are now available for the treatment of Europe’s ... See full document

32

European Medicines Agency. The European Medicines Agency in 2006. Summary of the twelfth annual report of the EMEA

European Medicines Agency. The European Medicines Agency in 2006. Summary of the twelfth annual report of the EMEA

... The Board has been closely following the Agency’s achievements in 2006. The EMEA has made considerable efforts to increase its outreach to patients and healthcare professionals by providing them more and better ... See full document

37

European Medicines Agency. Annual report 2009

European Medicines Agency. Annual report 2009

... the European Medicines Agency, and the European Commission's Scientific Committee on Emerging and Newly Identified Health Risks ...The report recommended that surveillance activities be ... See full document

81

European Medicines Agency. Annual report highlights 2010

European Medicines Agency. Annual report highlights 2010

... the Agency currently stands and making preparations for the future. A report on the evaluation of the Agency, carried out by Ernst & Young, was published at the beginning of the ...The ... See full document

16

European Medicines Agency. Annual report 2010

European Medicines Agency. Annual report 2010

... a report on the evaluation of the European Medicines Agency and the European medicines network as a ...the European Commission. The report shows that the ... See full document

83

European Medicines Agency. Highlights 2008. Summary of the European Medicines Agency's annual report for 2008

European Medicines Agency. Highlights 2008. Summary of the European Medicines Agency's annual report for 2008

... of medicines move increasingly beyond the traditional spheres of Europe and North America, regulators are becoming more keenly aware of the need for international cooperation on ensuring that safe and ethical ... See full document

17

European Medicines Agency. Report on annual workshop of the European Network of Paediatric Research at the EMA (Enpr-EMA), 27 & 28 June 2013

European Medicines Agency. Report on annual workshop of the European Network of Paediatric Research at the EMA (Enpr-EMA), 27 & 28 June 2013

... Innovative Medicines Initiative (IMI), a public/private partnership between the European Commission and EFPIA, funds the European Patients' Academy on Therapeutic Innovation (EUPATI), a patient-led ... See full document

6

European Medicines Agency. Annual report 2011. Overview of the Agency's contribution to science, medicines and health in the European Union

European Medicines Agency. Annual report 2011. Overview of the Agency's contribution to science, medicines and health in the European Union

... authorised medicines, the Agency has progressed its collaboration with the European Network for Health Technology Assessment (EUnetHTA), a body representing the HTA bodies from across ...the ... See full document

64

European Medicines Agency. Annual report highlights 2009

European Medicines Agency. Annual report highlights 2009

... the Agency devoted most attention in 2009 was the outbreak and rapid global spread of the H1N1 influenza ('swine flu') ...of European citizens – demonstrated to Europe and to the world that the ... See full document

7

European Medicines Agency. Tenth annual report of the European Medicines Agency 2004

European Medicines Agency. Tenth annual report of the European Medicines Agency 2004

... The Agency completed 2 urgent safety restriction (USR) procedures for centrally authorised products during 2004, introducing warnings into the marketing authorisation of the two medicinal ...The Agency ... See full document

130

European Medicines Agency. Annual report 2012

European Medicines Agency. Annual report 2012

... A number of tools were put in place or strengthened in 2012 to address the need of generating relevant new sources of evidence. These tools now need to be systematically utilised and further integrated to deliver ... See full document

52

European Medicines Agency. Annual report of the European Medicines Agency 2007

European Medicines Agency. Annual report of the European Medicines Agency 2007

... − Promoting access to vaccines against the major epizootic diseases of domestic livestock has remained a high priority for the Agency, in particular with respect to avian influenza and bluetongue. Bluetongue is an ... See full document

138

European Medicines Agency. Annual report of the European Medicines Agency 2008

European Medicines Agency. Annual report of the European Medicines Agency 2008

... The objectives of the sampling and testing programme, derived from the legal requirements, are to supervise the quality of centrally authorised medicinal products placed on the market and to check compliance of these ... See full document

158

European Medicines Agency. Annual Report 2009. Annexes

European Medicines Agency. Annual Report 2009. Annexes

... The Agency issues plasma master file (PMF) and vaccine antigen master file (VAMF) certificates of a medicinal product in conformity with the arrangements laid down by Community ...The Agency PMF/VAMF ... See full document

101

European Medicines Agency. Annexes of the annual report 2010

European Medicines Agency. Annexes of the annual report 2010

... Expediting Patients’ Access to Medicines by Improving the Predictability of Drug Development and the Regulatory Approval Process. Workshop on Predictable Outcomes September 30–October 1, 2008 Washington, DC. ... See full document

107

European Medicines Agency. Annexes of the annual report 2011

European Medicines Agency. Annexes of the annual report 2011

... of medicines after authorisation (‘pharmacovigilance’) is an important part of the work of the national competent authorities and the European Medicines ...The Agency receives safety reports ... See full document

117

European Medicines Agency. Annual report of the European Medicines Agency 2005

European Medicines Agency. Annual report of the European Medicines Agency 2005

... In 2005, the CVMP also reconsidered its previous opinion on the referral procedure for Micotil 300 (tilmicosin), initiated in 2004 to investigate concerns regarding user safety following an accidental human fatality ... See full document

112

European Medicines Agency. Summary of the annual report of the European Medicines Agency 2005

European Medicines Agency. Summary of the annual report of the European Medicines Agency 2005

... The results presented in this Annual Report prove that the EMEA ably faced up to its many challenges in 2005. On behalf of the Management Board, therefore, I would like to thank the personnel of the EMEA ... See full document

23

European Medicines Agency. Annual report of the European Medicines Agency 2006

European Medicines Agency. Annual report of the European Medicines Agency 2006

... Assessment Report in the DCP no longer prevents the issue of disagreement on the grounds of potential serious risk to public health from being referred to the ... See full document

134

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