EBE – the European Trade Association representing biopharmaceutical companies of all sizes.
About EBE
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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17 Apr 2019

Health industries welcome unprecedented progress leading to an adoption of Horizon Europe, its areas for missions and partnerships

Brussels, 17 April 2019 The six undersigned European health industry associations representing small and large companies welcome the Council and the European Parliament agreement on the Horizon...

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26 Nov 2018

Health industries call for a rapid adoption of Horizon Europe, its missions and partnerships

Brussels, 26 November 2018 - Health industries call for a rapid adoption of Horizon Europe, its missions and partnerships  The six undersigned European health industry associations are ambitious...

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11 Dec 2019

EBE-EFPIA Reflection Paper: Conformity with the relevant General Safety Performance Requirements listed in the European Medical Device Regulation 2017/745: Case study for a prefilled pen (prefilled syringe assembled with autoinjector parts forming a single integral product regulated as a medicinal product)

Article 117 of the Medical Device Regulation (EU) 2017/745 (MDR) requires the Marketing Authorization Applicant to include a Notified Body Opinion on the device constituent, part of a single integral...

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15 Oct 2019

EBE Position Paper: “A Risk-Based Approach to Identity Sampling of Biological Drug Substances”

Good Manufacturing Practices require that the identity of materials received for use in the manufacturing of drug products is confirmed. However, the direct sampling of primary containers of biologica...

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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...

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12 Dec 2019

EBE-EFPIA Position Paper: Approach to Substantial Design Change of the Integral Medical Device Constituent Part Under Article 117: A Risk Based Approach

Since the issuance of the EMA/CMDh “Questions & Answers on Implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations (EU) 2017/745 and (EU) 2017/746), Rev.1”, 2...

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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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From Twitter

Last chance to register for the @EBE_EU regulatory conference on #ATMPs "Handling the ATMPs challenges to timely meet #patients needs". Registrations will close on 2 December. Register now: http://bit.ly/2LVsASt

Landscape of medicines development is rapidly evolving, regulatory science research needs to keep up. Today #RegScience2025 strategy is discussed with stakeholders @EMA_News. @EFPIA @EBE_EU @VaccinesEurope @EUCOPE @EuropaBio @aesgp @medicinesforEU presenting the industry view

Looking for partners, investors & funding opportunities?
The 25th annual #BIOEurope @EBDgroup is almost here!
📆Join us on 12 Nov from 9am to find out about #H2020 support, and meet us at the #EU booth 92 at the exhibition
👉 http://europa.eu/!Pg94Kd

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