[PDF] Top 20 European Medicines Agency. Annexes of the annual report 2011

... Büttel IC, Chamberlain P, Chowers Y, Ehmann F, Greinacher A, Jefferis R, Kramer D, Kropshofer H, Lloyd P, Lubiniecki A, Krause R, Mire-Sluis A, Platts-Mills T, Ragheb JA, Reipert BM, Schellekens H, Seitz R, Stas P, ... See full document

... introduction of new procedures and creation of a new scientific committee dedicated to implementing the EU’s Paediatric Regulation, which came into force on 26 January 2007. With the foundation of this new legislative ... See full document

... 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

... 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

... 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

... 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

... 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

... this Annual Activity Report, represent only the (contingent) assets, (contingent) liabilities, expenses and revenues that are under the control of this Directorate ... See full document

... the European Commission is mandated to prepare such guidance by the Clinical Trials Regulation? Should Enpr-EMA lobby to allow non-written consent information ... See full document

... I have taken on the responsibility of ESA Director-General at a particularly challenging and complex time for the development of nuclear energy. I am strongly convinced that this climate of increasing uncertainty adds to ... See full document

... consolidating European Union acts, making available all tender notices in the Supplement to the Official Journal, producing publications in all forms, reprinting publications and correcting errors for which the ... See full document

... -In line with the requirements of the Financial Regulation and the Delegation Act, the Directors General of parent DGs have verified and approved the internal control system and procedures of the Agency before ... See full document

... The majority of positive CHMP opinions adopted in 2008 related to cancer medicines, followed by anti- infectives and medicines for the treatment of neurological and central-nervous-system conditions. One ... See full document

... 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

... our European partners on stimulating innovation in the pharmaceutical sector, strengthening our safety-monitoring of medicines, exchanging expertise on a wide range of issues, and forging closer relations ... See full document

... the Agency to the Heads of Medicines Agencies (HMA) action plan to promote the availability of veterinary medicines and to the European Technology Platform for Global Animal Health, as well as ... See full document

... 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

... human medicines intended for the treatment of HIV/AIDS, cancer, diabetes, neurodegenerative disorders and for all designated orphan medicines intended for the treatment of rare ...veterinary ... See full document

... 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

... in 2011) as did the success rate of stand-alone extension applications (83% vs 84% in ...in 2011) and even lower for applications from small and medium-sized enterprises (SMEs) (37% vs 50% in ... See full document