Based on the evolution of the pilot project for the new Clinical Trial Regulation, the FAMHP made an update on the guidance document to assist clinical trials sponsors as part of the pilot project for clinical trials.
Update on the guidance document to assist clinical trials sponsors as part of the pilot project of the FAMHP
The Federal Agency for Medicines and Health Products (FAMHP) is holding a symposium on vaccines on Friday 6 December 2019. The symposium will highlight certain current challenges in the development of new vaccines and the improvement of existing vaccines. Spekers will also talk about the role of various Belgian public institutions in bringing vaccines to market and monitoring them.
At its July 2019 meeting, EMA’s paediatric committee (PDCO) elected Koenraad Norga from Belgium as its new chair, for a three-year mandate starting in September. Professor Norga will replace Dr Dirk Mentzer who is retiring as PDCO Chair, having served the maximum of two three-year mandates.
The European Commission is looking for experts for panels on medical devices and in-vitro diagnostics
Later this year, the European Commission will launch a call for experts in medical devices and devices for in-vitro diagnostics. They will form expert panels to provide advice and assess new risky devices.
The Federal Service for Public Health, Food Chain Safety and Environment and the Federal Agency for Medicines and Health Products (FAMHP) want to know your opinion on vaccine plan B/BE/19/BVW4 which will be using a genetically modified vaccine against Ebola. This vaccine is meant to protect Belgian employees of Doctors Without Borders from Ebola in the Democratic Republic of the Congo. You can share your opinion until July 25.
The law on allogenic ATMPs dated 30 October 2018 changes various elements in the law dated 19 December 2008 regarding human tissue products (HTP) with the intention of medical application on humans or for scientific research.