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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.

Big opportunities in big data, but EMA and industry just getting started

Big opportunities in big data, but EMA and industry just getting started

The heads of all the national EU medicines agencies (HMA) and the centralised European Medicines Agency (EMA) have just released a report from a joint big data taskforce, which sets out ... The report says big data represents a huge shift away from when

Latest news

  • European Medicines Agency departs London ahead of Brexit European Medicines Agency departs London ahead of Brexit

    chain, saying it is stockpiling to ensure it can continue to provide the “120 million packs of medicines we import to the UK from Europe each year.”. ... Novartis also urges NHS trusts and pharmacists to adhere to the government’s advice not to

  • eConsent: Busting regulatory myths eConsent: Busting regulatory myths

    The US Food and Drug Administration (FDA), The European Medicines Agency (EMA), The Office of the Human Research Protection Program (OHRP), The Health Insurance Portability and Accountability Act of 1996 (HIPAA)

  • FDA fast tracks Novartis’ SMA gene therapy FDA fast tracks Novartis’ SMA gene therapy

    life. We are committed to flexibly partnering with healthcare stakeholders to ensure appropriate access to our medicines.". ... The drug is also currently under review in Europe, where the European Medicines Agency has said the company can expect a

  • As Brexit looms, UK medicines agency head Hudson announces departure As Brexit looms, UK medicines agency head Hudson announces departure

    The news adds to the huge upheaval at the agency, which faces huge uncertainty post-Brexit, with its future place within the European Medicines Agency (EMA) regulatory network still undecided. ... The financial impact of this is already affecting the

  • Decision time for Brexit Decision time for Brexit

    model’ for the UK’s relations with the European Medicines Agency. ... This would see the UK’s regulator the MHRA part of the EMA network for medicines regulation, but unable to influence decision-making.

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Latest Intelligence

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Latest appointments

  • Emotive grows medical writing capacity Emotive grows medical writing capacity

    Dr Silvana Bardelli and Dr Ann Gilliat join the agency. Healthcare Communications agency Emotive has strengthened its medical writing team with the addition of two new hires. ... Dr Silvana Bardelli (pictured right) joins as a senior medical writer

  • 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

    He joins with immediate effect. 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

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Latest from PMHub

  • Solaris Health looks at 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

  • 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

  • Clinical data Transparency

    Amidst extensive criticism the pharmaceutical industry has called for more carrot as an incentive for companies to begin releasing their data; and in the face of two lawsuits even the European ... Medicines Agency (EMA) has had to defend its position on

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