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...
Read moreRegistration now open: 8th EBE annual regulatory conference on ATMPs – “Handling the ATMPs challenges to timely meet patient needs”
“Handling the ATMPs challenges to timely meet patient needs” The 8th annual regulatory conference organised by the European Biopharmaceutical Enterprises (EBE) 4 December 2019, Hotel...
Read moreEBE-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 moreEBE-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 moreEBE Reflection Paper: Medicinal product incorporating a drug delivery device component: An Industry Perspective on developing an efficient, ‘End to End’ Control Strategy
A cross-industry working group within EBE (European Biopharmaceutical Enterprises) has recently focused on EU specific topics relating to those integral combination products which are regulated as med...
Read moreEBE 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...
Read moreHealth 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...
Read moreExit 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...
Read moreEBE Concept Paper – Management and Control of Raw Materials Used in the Manufacture of Biological Medicinal Products and ATMPs
Brussels, 17 December 2018 Effective management and control of raw materials (RM) used in the manufacture of biological medicinal products including advanced therapy medicinal products (ATMPs) requ...
Read moreHealth 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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