The current applied models in regulatory affairs and HTA management require some readjustment if Europe is going to be able to continue to compete on a global basis in the oncology therapeutic area. The Biotherapy Development Association (BDA) e.V. are privileged to have been invited by BfArM in Bonn to host this important one day meeting on 9th March 2011. The objectives of this BDA meeting are: - to provide a forum where all stakeholders concerned with oncology developments can meet to review the current situation and reach a consensus in a transparent manner; - to enable constructive discussions by a multi-disciplinary group comprising senior regulators from EMA together with academic oncologists, academic HTA specialists, specialists from the pharmaceutical industry and patient advocacy groups. This meeting will be of interest to the following groups: Academic oncologists and HTA specialists, regulators from the national regulatory authorities, senior industry executives from the pharmaceutical and biotechnology industries who are concerned with regulatory affairs, HTA and market access programmes.