05 Apr 2017

Podcast: How To Support Advanced Therapies and Breakthrough Medicines in Europe

On the occasion of  the first DIA BioVenture day on 28 March 2017 in Glasgow, Menno Aarnout, Wolfgang Stoiber and EBE's Barbara Freischem discussed options for solutions to support the development and funding of Advanced Therapies and Breakthrough Medicines in Europe....

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31 Mar 2017

Open Call to all ATMP developers

Invitation for ATMP-developers to help improve product development and its regulation  Advanced Therapy Medicinal Products (ATMPs) are medicinal products including gene therapies, somatic cell therapies and tissue engineered products. They are characterised by their innovative character, frequently addressing disease with high unmet medical need. Despite considerable development activity in this dynamic field, a limited number of ATMPs have received Market Authorisation in the European Union. There is a growing urgency to understand which factors are associated with the advancement of ATMPs through the medicines life-cycle....

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23 Feb 2017

New project: success and failure in the development and commercialisation of ATMP products

With recent developments in innovative technologies, new opportunities arise to address demands of an aging population, as well as for diseases with high unmet medical needs. ...

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01 Feb 2017

Event report from the 5th annual regulatory conference on ATMPs organised by EBE in collaboration with the EMA

The 5th annual regulatory conference on ATMPs, organised by EBE with the support of the European Medicines Agency (EMA) took place on 16 December 2016, in London, UK. The event saw a packed house - the greatest participation so far....

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23 Jan 2017

Podcasts from the 5th annual regulatory conference on ATMPs, organised by EBE in collaboration with the EMA

On the occasion of the  5th annual conference on the regulation of ATMPs on 16 December 2016 in London, some presenters spoke to us on their work and their thoughts on how to improve access for patients to these potentially curative medicines....

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07 Nov 2016

Webinar: ‘How Can Legislation Help Make Personalised Medicines a Reality?’

Recently, compromise texts were agreed by the European Commission, Council and Parliament on new legislation on Medical Devices (MD) and on In Vitro Diagnostic (IVD) Medical Devices (MD).  A key issue that remains to be dealt with is the reimbursement of diagnostic tests that are necessary to personalised medicines....

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27 Sep 2016

Podcast: “Funding Europe’s Biotech Ecosystem for Success”

This podcast provides vital insights into the pressing issues facing EU biotech businesses, and provides some answers that tackle Europe's funding issues....

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03 Aug 2016

A Biopharmaceutical Industry Perspective on the Control of Visible Particles in Biotechnology-Derived Injectable Drug Products

For the past two years, representatives from eight different pharmaceutical companies which manufacture biotechnological products have been discussing visible particles....

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24 Jun 2016

EBE Webinar: “Maintaining Europe’s Lead In Regenerative Medicine – New Approaches and Programmes”

Webinar - 1 July 2016 - 11.45-12.30 CET While the EU has had a global lead in ATMP technologies and regulation policy, other countries are moving aggressively into the space. The Japanese "Sakigake" accelerated pathway for regenerative medicines, as well as initiatives such as the UK's EAMs and EMA's PRIME are such examples. What are the National Governments and European Commission doing specifically to ensure that ATMP technologies are continued to be developed and commercialised in Europe?  ...

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23 Jun 2016

17 June 2016: adoption of the Regulation on In-Vitro Diagnostic (IVD) Medical Devices

Brussels, 17 June 2016: The European Biopharmaceutical Enterprises, EBE, and the European Federation of Pharmaceutical Industries and Associations, EFPIA, welcome the agreement reached between the Council of Ministers and the European Parliament Health Committee (ENVI) on the adoption of the Regulation on In-Vitro Diagnostic (IVD) Medical Devices. This Regulation, adopted alongside the Regulation on Medical Devices, will ensure the increased safety of IVD medical devices and will allow patients to benefit from innovative healthcare solutions in a timely manner....

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