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 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...
Read moreEBE-EFPIA Position Paper on Next Generation Sequencing (NGS)
Next generation sequencing (NGS), also known as high-throughput sequencing, is a DNA and RNA sequencing technology which has revolutionized genomic research. Today, an entire human genome can b...
Read moreJoint EBE-EFPIA Position on CE Marking
A Topic Group of the joint Personalised Medicine Working Group has been developing a slide deck highlighting the position of the pharmaceutical industry on the need to consider a risk-based a...
Read moreEBE View on the SPC Manufacturing Waiver
The European Biopharmaceutical Enterprises (EBE) has just released its latest position paper, raising concerns on how the SPC manufacturing waiver will affect innovative biopharmaceutical companies,...
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