News

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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13 Jun 2016

EBE Annual Meeting 2016: IMI – Opportunities and Challenges for developing Advanced Therapies

Watch here the recording of the live broadcast IMI – opportunities and challenges for developing Advanced Therapies (17h00 - 19h00 CET)A keynote speech by Pierre Meulien, Executive Director IMI, followed by a moderated panel discussion on the opportunities for EBE members....

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07 Jun 2016

EBE webinar live from BIO: “Accessing the European Market: What Do You Need to Know and When Do You Need to Know It?”

June 8th, 2016 - 17-18h CET, 8-9h PDT (California) A spotlight on the specifics for cell, gene and tissue therapy Watch the webinar here     ...

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12 May 2016

EBE Bioburden at CMC Strategy Forum Europe 2015

A Risk-Based Approach to Setting Sterile Filtration Bioburden Limits...

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12 May 2016

Podcast with Eduardo Bravo – TiGenix – and Samantha Parker – Lysogene – on Adoption of New technologies

Facing the current challenges of coming to market with new ATMPs in Europe, particularly from the standpoint of the barriers to Adoption; this podcast aims to explore in depth several of the topics ar...

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