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European Medicines Agency

This page shows the latest European Medicines Agency news and features for those working in and with pharma, biotech and healthcare.

UK pharma leader warns on ‘untenable’ Brexit deal

UK pharma leader warns on ‘untenable’ Brexit deal

Thompson pointed out that the European Medicines Agency chief Guido Rasi is now predicting that there will be medicines shortages on the continent, despite the best efforts of the regulator and ... Watch the full evidence session at the Exiting the

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Latest appointments

  • Emotive grows medical writing capacity Emotive grows medical writing capacity

    Emotive grows medical writing capacity. Dr Silvana Bardelli and Dr Ann Gilliat join the agency. ... Dr Silvana Bardelli (pictured right) joins as a senior medical writer following a five year career at the Italian Medicines Agency serving as its young

  • Zelluna appoints Miguel Forte as CEO Zelluna appoints Miguel Forte as CEO

    Prior to his new role, Forte has held roles for Bone Therapeutics, TxCell, the European Medicines Agency, and  UCB to name a few.

  • Bone Therapeutics strengthens clinical development team Bone Therapeutics strengthens clinical development team

    His career to date has also seen him hold positions such as vice president, global medical affairs at UCB, as well as senior positions at the European Medicines agency, Bristol-Myers

  • EMA’s head of international affairs steps down EMA’s head of international affairs steps down

    The European Medicines Agency's (EMA) Emer Cooke has resigned as head of international affairs, to be replaced ad interim by Agnès Saint-Raymond. ... She has served as head of international affairs since 2013, and is leaving the agency to pursue a new

  • EMA appoints Luc Vanheel as head of administration EMA appoints Luc Vanheel as head of administration

    The European Medicines Agency (EMA) has named Luc Vanheel as the new head of its administration division. ... Vanheel has previously worked as finance and business services director and deputy director and head of plans and programmes at the European

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  • The gene therapy revolution

    As an example, in the case of Strimvelis (autologous CD34. cells transduced to express adenosine deaminase [ADA]), the first ex vivo stem cell gene therapy approved by the EMA (European Medicines ... and the Italian Medicines Agency, known as AIFA,

  • Brexit and Pharma: A match made in hell.

    The demand for efficiency and expediency won out when the European Medicines Agency (EMA), a decentralized agency of the EU, began operating in 1995 from its base in London. ... 1. European Federation of Pharmaceutical Industries and Associations. The

  • The Heart of the Matter 7: Reality Dawns

    Likewise, European pharmacovigilance legislation implemented in 2012 means the European Medicines Agency (EMA) is now requesting post-marketing observational studies as part of its approval processes. ... In tandem, as the limitations of the 'gold

  • Getting ready for the Identification of Medicinal Products

    Europe will be the first region to implement IDMP standards; the European Medicines Agency (EMA) will publish the full implementation guidelines for IDMP in 2015, leaving those who wait little time

  • A forward march for adaptive designs

    Very recently the European Medicines Agency (EMA) issued a qualification opinion on a novel statistical methodology for dose finding trials which employs adaptive modelling to optimise the analysis of dose-response ... Also late last year, the Center for

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