EBE Working Structures Remit
Advanced Therapies (joint Working Group with EFPIA)
The role of the Advanced Therapies WG is to support a consistent and harmonised regulatory framework for advanced therapies. The WG provides industry input on relevant regulatory issues and also acts as a point of contact for discussions with the EMA Committee of Advanced Therapies. The WG has recently developed a paper on hospital exemptions and will be providing input to the Commission review on the Advanced Therapy Regulation.
Biomanufacturing Working Group
The objectives of the EBE Bio-Manufacturing Working Group are to: Raise the awareness of biotech manufacturing in the technical and quality arena. Ensure the protection of the patient and promote consistent application of requirements by industry and competent authorities. Provide a forum for the exchange of information and good practices between companies to develop and communicate technical positions externally.
Biotherapeutics Working Group
The objectives of the Biotherapeutics Working Group are to contribute industry expertise to the development of new legislation for biological. It is a forum for industry expertise to provide active follow-up on relevant topics such as tendering, traceability, SmPC labeling for biosimilar products.
Innovation and Funding Models Working Group
The role of the Innovation and Funding Models Working Group is to support the development of attractive entrepreneurial conditions for the biopharmaceutical industry, working together with the relevant EU institutions, as well as to develop programmes that support greater connectivity in the European Biotech-Pharma ecosystem. Its role is also to represent Biotech/SMEs perspective in EU’s public research and innovation funding schemes (eg Horizon 2020, IMI II) and to provide research partnering opportunities for EBE members.
Personalised Medicine (joint Working Group with EFPIA)
The mission of the Personalised Medicine Working Group is to promote personalised medicine towards key stakeholders, and particularly politicians, to explain how it can improve patients’ health by delivering the right medicine to the right patient at the right time. The WG also aims to ensure a favorable legislative environment to allow innovative medicines to be developed. The group plays a leading role in the recast of the In Vitro Diagnostics – Medical Devices Regulation.
Allergen Immunotherapy Task Force
The Allergen Immunotherapy Task Force unites experts from biopharmaceutical companies with a focus on allergen immunotherapy. It carries out a project investigating the burden of disease for allergic patients, and looks at the need for harmonisation of the regulatory framework for allergens in Europe.
EBE Staff liaison: Audrey Wolf
Cancer Control Task Force
The Cancer Control (CanCon) Task Force prepared and provided industry input into the EU Expert Group on Cancer Control, on which EBE represented the biopharmaceutical industry. The Task Force ended in March 2017.
LEAD: Thomas Buechele, F. Hoffmann-La Roche
EBE STAFF LIAISON: Audrey Wolf
Public Affairs Network
The Public Affairs network’s mission is to efficiently communicate EBE messages externally as biopharmaceutical industry representatives. The network needs to be aware of the positioning and key messages of all working groups to adapt the main messages and develop advocacy plans on issues that EBE is leading, e.g. In Vitro Diagnostics Regulation recast, or tendering for biosimilars. The group meets on an as needed basis, but at least once a year.
Regulatory & Technical Affairs Network
The objectives of the Regulatory & Technical Affairs network are to contribute industry expertise to the development of new regulatory frameworks, guidelines and standards of relevance to biopharmaceutical companies operating in Europe, promoting the exchange of good practices fostering the development of safe, efficacious and high-quality medicines, and providing a forum for expert information exchange between members and the establishment of Good Practices. The group convenes as needed, but at least once a year.