News

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
12 Jun 2019

EBE 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 more
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...

Read more
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...

Read more
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...

Read more
17 Dec 2018

EBE 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 more
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...

Read more
19 Oct 2018

EBE-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 more
06 Sep 2018

Joint 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 more
02 Aug 2018

EBE 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,...

Read more
1 2 3 8