Republished from: https://ec.europa.eu/health/human-use/events/ev_20190617_en
In the beginning of this century, the EU put in place two regulations: one for medicines for rare diseases (‘orphans’) in 2000 and one for medicines for children in 2006. The ultimate objective of the legislation was to increase therapeutic choices for children and patients suffering from rare diseases. How? By bringing more medicinal products for those therapeutic areas to the market.
Following the publication of the 2017 Commission Report on the Paediatric RegulationSearch for available translations of the preceding link•••, the European Commission also announced a joint evaluation of both the paediatric and the orphan Regulations covering their effects and impacts so far.
To conduct this evaluation, the Commission will use the outcomes of various recent studies and of public and targeted consultations that were finalised earlier this year.
DG SANTE also aims to have an in-depth discussion with Member States and stakeholders and allow your voice and thoughts on both regulations to be heard!
Thus, a conference will be held in Brussels on June 17, which will bring together representatives from Member States and other stakeholders (patients, academia, healthcare professionals and industry associations).
In order to ensure not only a balanced representation of all interested groups but also the widest possible geographical coverage across the EU, there will be a 2-step registration process. First, the deadline for expression of interest [link to the registration website] to attend the conference is 15 May. Then all selected participants will be contacted by 17th of May by e-mail to confirm their participation.
Please do not make any travel arrangements before receiving a confirmation from the Commission.
You can find a preliminary program for the day hereSearch for available translations of the preceding link••• including an outline for the topics of the break-out sessions.