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26 Aug 2019 - Position Paper

EBE-EFPIA Position Paper: An Industry Perspective on Article 117 of the EU Medical Device Regulation: Labelling Requirements for Prefilled, Non-Reusable, Integral Drug-Delivery Device Combination Products

Prefilled, non-reusable, integral drug-device combinations (DDCs) are regulated as medicinal products, if the intention is to administer the medicinal product to the patient. However, the device compo...

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12 Aug 2019 - News

EBE-EFPIA Position Paper: An Industry Perspective on Article 117 of the EU Medical Device Regulation: Clinical Requirements for Prefilled, Single-Use, Integral Drug-Device Combination Products

Prefilled, single-use, integral drug-device combinations (DDCs) are regulated as medicinal products. However, the device component needs to conform with “relevant” General Safety and Performance R...

Read more
12 Aug 2019 - Position Paper

EBE-EFPIA Position Paper: An Industry Perspective on Article 117 of the EU Medical Device Regulation: Clinical Requirements for Prefilled, Single-Use, Integral Drug-Device Combination Products

Prefilled, single-use, integral drug-device combinations (DDCs) are regulated as medicinal products. However, the device component needs to conform with “relevant” General Safety and Performance R...

Read more
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Press Releases

14 May 2019

EBE announces the appointment of Michele Antonelli as Vice-President

Brussels, 14 May 2019 – The European Biopharmaceutical Enterprises (EBE) is pleased to announce the appointment of Mr Michele Antonelli, Chief Executive Officer of Stallergenes Greer, as EBE Vice-Pr...

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Position Papers

26 Aug 2019

EBE-EFPIA Position Paper: An Industry Perspective on Article 117 of the EU Medical Device Regulation: Labelling Requirements for Prefilled, Non-Reusable, Integral Drug-Delivery Device Combination Products

Prefilled, non-reusable, integral drug-device combinations (DDCs) are regulated as medicinal products, if the intention is to administer the medicinal product to the patient. However, the device compo...

Read more
12 Aug 2019

EBE-EFPIA Position Paper: An Industry Perspective on Article 117 of the EU Medical Device Regulation: Clinical Requirements for Prefilled, Single-Use, Integral Drug-Device Combination Products

Prefilled, single-use, integral drug-device combinations (DDCs) are regulated as medicinal products. However, the device component needs to conform with “relevant” General Safety and Performance R...

Read more
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Publications

19 Feb 2019

Exit Strategies for SME Life Science Companies in the EU

When funding life science companies, investors need realistic expectations on how to recover their investment and, potentially, returns on their investment. A number of options exist, commonly c...

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20 Jun 2018

Incentives, IP and Smaller Companies: The Story of uniQure

Download the Case Story in PDF format here uniQure, based in Amsterdam in the Netherlands  and Lexington, Massachusetts, USA, is developing curative gene therapies for patients with severe geneti...

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