Please login to the form below

Not currently logged in
Email:
Password:

European Medicines Agency

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

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)

Latest news

  • 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

  • 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.

  • Entering the era of digital trials Entering the era of digital trials

    For example, in September the European Medicines Agency provisionally ruled that more robust data is needed before the aforementioned DMD wearable is used to gather primary endpoint data. ... The agency thinks the idea is sound, though. As sponsors,

  • Orchard surpasses IPO expectations, raising $200m Orchard surpasses IPO expectations, raising $200m

    flow. Orchard now joins a cluster of European biotechs, including the likes of GW Pharmaceuticals and Genmab, that are worth 1bn or more. ... just got a PRIME designation from the European Medicines Agency (EMA).

  • Medical cannabis now available on prescription, for some Medical cannabis now available on prescription, for some

    An expert panel of clinicians has also been set up to assess applications for licences to prescribe cannabis-based medicines. ... particularly as the European Medicines Agency (EMA) has said it will defer to member states on the issue.

More from news
Approximately 1 fully matching, plus 698 partially matching documents found.

Latest Intelligence

More from intelligence
Approximately 0 fully matching, plus 41 partially matching documents found.

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

More from appointments
Approximately 0 fully matching, plus 18 partially matching documents found.

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

  • 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

  • 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

More from PMHub
Approximately 0 fully matching, plus 5 partially matching documents found.

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Wisepress

Wisepress is a medical bookseller promoting and selling books worldwide, both online and via the 200 European medical conferences that...

Latest intelligence

Report: Achieving launch excellence in the challenging healthcare markets of today
Our in-depth report is based on original data and expert interviews, which coupled with our own experience, ensures we give you the best recommendations for achieving launch success in challenging...
What is blockchain and why should i care - Richard Springham
Four Health - Emerging Technologies The power of blockchain lies in the fact it can prove that a unique event occurred at a certain time with out the need to...
NHS medicines optimisation milestone
Steve How, Paul Midgley and Oli Hudson, of the Wilmington Healthcare Consulting Team, explore the implications of Adalimumab’s recent European patent expiry...

Infographics