Position Papers

09 Mar 2017

EBE, EFPIA and IFPMA position paper “Considerations for physicians on switching decisions regarding biosimilars”

Switching describes a physician's decision to exchange one product that a patient receives for another. With the introduction of biosimilars, physicians may be encouraged to switch patients...

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12 Oct 2016

EBE Position Paper ” A Risk-based Approach to Setting Sterile Filtration Bioburden Limits”

As part of the submission supporting the request for a marketing authorisation, medicines must demonstrate that they are of appropriate quality, which often includes a demonstration of sterility.  B...

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19 Sep 2016

The European biotech ecosystem: EBE position paper recommends how to make funding go further

Brussels, 19 September 2016 The European Biopharmaceutical Enterprises (EBE) today published a White Paper that scrutinises funding available for innovative biopharmaceutical entrepreneurs in Europe a...

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16 Jun 2016

Consultation on IMI Advanced Therapies Concept Paper

IMI, in collaboration with key stakeholders, has developed a concept paper  on advanced therapies which is posted for public consultation. The aim of the concept paper is to identify the potential...

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22 Feb 2016

EBE Briefing Paper: Biosimilarity and Comparability after Manufacturing changes: Can a biologic become a biosimilar of itself?

22 Feb 2016

EBE Position Paper: Tissue and Cells for the Manufacture of Allogeneic Medicinal Products for multiple patients and/or indications

This Position Paper sets out the challenges, and recommends clarification and convergence of donor testing requirements, development of more sensitive test methods and of international standards...

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08 Apr 2015

EBE-EPEMED Position Paper on Companion Diagnostics

In September 2012, the Commission proposed a framework that defines how medical devices (MDs) and in-vitro diagnostics (IVDs) may be placed on the EU market. Subsequently, the Parliament has made a nu...

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17 Feb 2015

EBE Position Paper on Companion Diagnostics (CDx) – February 2015

In September 2012, the Commission proposed a framework that defines how medical devices (MDs) and in-vitro diagnostics (IVDs) may be placed on the EU market.  Subsequently, the Parliament has made a...

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16 Dec 2013

EBE position paper on the use of Omics technologies in the development of personalised medicine

The European Commission (EC) has recently published a report on ‘Use of '-omics'technologies in the development of personalised medicine’....

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03 Oct 2013

European Biopharmaceutical Enterprises’, EBE’s, position on European Medicines Agency’s Draft Policy for Clinical Trial Data Sharing

European Biopharmaceutical Enterprises, EBE, a specialised group of European Federation of Pharmaceutical Industries and Associations, EFPIA, represents the voice of biopharmaceutical compan...

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