30 September-1 October 2014, London, UK
The aim of this conference is to discuss on a high level how the EU paediatric regulation – now in force since 2007 – is working and how it contributes to children’s health. This legislation has transformed paediatric drug development from a topic discussed by a few interested paediatricians, clinical pharmacologists and regulators into an issue that is broadly known to the pharmaceutical industry and regulatory authorities, and to a lesser degree to the clinical world.
More than 1000 PIP decisions are now published on the EMA website, and virtually everybody within pharmaceutical industry has heard of paediatric investigation plans and waivers. The EU Commission has published a 5-year report, and will submit a 10-year report to the European Parliament and Council in 2017. The conference will include a discussion on the preparedness for this 10-year report; strategic thoughts within the EMA on how to streamline paediatric development and a session dedicated to paediatric oncology.
On day 1 participants will discuss more specialized and hot topic issues in four breakout sessions. This will allow participants to discuss face-to-face with all stakeholders, something which otherwise usually occurs only by email or phone. Together with several other high-level experts, the SIOPE President, Prof Gilles Vassal, will speak about the EU Perspective on Paediatric Oncology (1st October, 9:00). Questions on any topic relating to the Agency’s activities can be submitted before the conference to email@example.com, and will be answered by the Paediatric Medicines office at the EMA.