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.
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.
The Public Affairs network 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.
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.
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.
The Cancer Control (CanCon) Task Force prepares and provides industry input into the EU Expert Group on Cancer Control, on which EBE represents the biopharmaceutical industry.
LEAD: Thomas Buechele, Roche
EBE STAFF LIAISON: Audrey Wolf