The EU paediatric regulation has now been in force since 2007 and has considerably changed the place of paediatric drug development in the general drug development process. Drug development is no longer possible without considering children. The aim of this conference is to discuss on a high level where we stand with paediatric drug development in Europe, where the partners in drug development, i.e. clinicians, industry, regulators and others, agree and where they disagree, in which area the EU regulation can be considered a success, where the regulation might be modified in the future, where and how its daily interpretation by the EMA will be modified, and where collaboration between the involved players can be improved.
The EFGCP / DIA / EMA Paediatric Conference allows an open discussion between academics, clinicians, regulatory authorities, parents’ & patients’ associations and pharmaceutical industry about paediatric drug development.
The conference is an annual event that goes back to two series of annual conferences: a first one initiated in 2005 by EFGCP, and a second one initiated in 2007 by DIA. Both were organised in tight collaboration with the EMEA, which in 2011 changed its name to EMA. Since 2010 the two conference series have been merged, and since 2011 EMA is officially co-producing the conference as an equal partner. The EU paediatric regulation has transformed paediatric drug development from a topic discussed by a handful of interested paediatricians, clinical pharmacologists and regulators to an issue that is broadly known within pharmaceutical industry, regulatory authorities, the clinical world and other institutions.
More than 1000 PIPs have so far been submitted, and virtually everybody within pharmaceutical industry has heard of the PIP requirement. The level of detail in the key elements of Paediatric Investigation Plan has been continuously discussed since the Paediatric Regulation came into force. In the 2011 conference, EMA announced that changes will come in this area; this year EMA will announce how these changes will look like. As in previous conferences, representatives from all stakeholders will give presentations, and on day 1, participants will have the choice between three breakout sessions to discuss specific issues in smaller groups. This will allow participants to exchange on eye level and face-to-face with their respective counterparts who otherwise interact predominantly by phone and only occasionally at face-to-face meetings.