6th EBE Annual Regulatory Conference “Realising the potential of advanced therapies for patients”
5 December 2017, CCT South Quay Venue – Thames Quay, 193 Marsh Wall, London, E14 9SG, United Kingdom Draft Agenda Register Ten years after adoption of the EU regulation on advanc...
Read moreEBE and EFPIA call on the EU Commission and Member States to improve transparency on Hospital Exemptions for Advanced Therapies
“Therapies for the future - Exploring solutions for innovative treatments in Europe” will take place at the European Parliament on 11 October 2017. In advance of this significant discussion...
Read moreARM, EBE, EFPIA and EuropaBio jointly publish a series of proposals to streamline requirements and accelerate approvals of clinical trials with new therapies that consist of or contain Genetically Modified Organisms (GMOs) in Europe
The Alliance for Regenerative Medicine (ARM), the European Biopharmaceutical Enterprises (EBE), the European Federation of Pharmaceutical Industries and Associations (EFPIA) and EuropaBio jointly publish a series of proposals to streamline requirements and accelerate approvals of clinical trials with new therapies that consist of or contain Genetically Modified Organisms (GMOs) in Europe....
Read moreEBE-EFPIA Set Out Policy Positions in Their Personalised Medicines Manifesto
The EBE-EFPIA Personalised Medicine Working Group have developed a Manifesto that aims to highlight policy elements that are considered essential to ensure that personalised medicines and their paired diagnostic tests, also called companion diagnostics, successfully reach patients....
Read moreEBE Webinar: IP and its crucial role in bringing innovative medicines to patients
20 June 2017 from 16H30 - 17H30 CET Europe has good science and sound Intellectual Property (IP) policies in place. These IP policies and other incentive offered by legislation when medicines are developed play a critical role in companies corporate and product development strategies....
Read moreFinal Call ATMP Survey: Help improve product development and regulation
Response deadline: 30 June 2017 Advanced Therapy Medicinal Products (ATMPs) are medicinal products including gene therapies, somatic cell therapies and tissue engineered products. They are characterised by their innovative character. Despite considerable development activity in this dynamic field, a limited number of ATMPs have received Marketing Authorisation in the European Union. There is a growing urgency to understand which factors are associated with the advancement of ATMPs through the medicines life-cycle....
Read moreWhat pricing and reimbursement policies to use for off-patent biologicals? – Results from the second EBE biological medicines policy survey
Objective: Biosimilar policies with a focus on uptake have received a lot of attention at national and regional level in the last few years. It is now 10 years since the first biosimilar was approved in the European Union, but do policies in the Member States take the differences between biological medicines and small-molecule generics into account? To map the policy landscape in Europe, European Biopharmaceutical Enterprises (EBE) has conducted a second round of its descriptive survey of pricing and reimbursement policies for off-patent biologicals. ...
Read morePodcast: EBE Plots Path from “Flawed Underfunded Biotech System”
During DIA’s first DIA BioVenture Day, Ms Freischem delivered a presentation titled Europe’s Flawed and Underfunded Biotech System, which she explores in this exclusive Global Forum podcast....
Read morePodcast: How To Support Advanced Therapies and Breakthrough Medicines in Europe
On the occasion of the first DIA BioVenture day on 28 March 2017 in Glasgow, Menno Aarnout, Wolfgang Stoiber and EBE's Barbara Freischem discussed options for solutions to support the development and funding of Advanced Therapies and Breakthrough Medicines in Europe....
Read moreOpen Call to all ATMP developers
Invitation for ATMP-developers to help improve product development and its regulation Advanced Therapy Medicinal Products (ATMPs) are medicinal products including gene therapies, somatic cell therapies and tissue engineered products. They are characterised by their innovative character, frequently addressing disease with high unmet medical need. Despite considerable development activity in this dynamic field, a limited number of ATMPs have received Market Authorisation in the European Union. There is a growing urgency to understand which factors are associated with the advancement of ATMPs through the medicines life-cycle....
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