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Update on the guidance document to assist clinical trials sponsors as part of the pilot project of the FAMHP

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.

Operation Pangea XII: FAMHP seizes 5,360 packages, containing almost 500,000 counterfeit or illegal products

In 2019, operation Pangea took on a new form. This operation focused on information collection, analysis and communication. For this twelfth edition, that took place from June 2018 to June 2019, the FAMHP provided the necessary data. Pangea is coordinated by INTERPOL and is specifically designed to intercept illegal and counterfeit medicinal products and devices.http://www.medicaments-par-internet.be

Save the Date: Register for the Vaccine Symposium on 6 December 2019

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.

Brexit: European Commission reminds enterprises to be well prepared

Brexit is coming very shortly. And it will have great consequences for many Belgian companies.

Save the date: Symposium on the new European legislation on veterinary medicines. What will change for you?

Europe has approved new legislation on veterinary medicines and medicated animal feeds. What does this mean and what will change concretely for the industry or veterinarian? Learn everything at the FAMHP symposium on November 19.

Belgian Koenraad Norga elected as new chair of EMA’s Paediatric Committee

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 FAMHP releases its annual report for 2018: patients remains at the centre of attention and an ongoing willingness to innovate and remain a quality partner

Improved communication with partner organizations, increased accessibility to innovation for patients with urgent medical needs, an increasingly significant presence on social media … 2018 was marked by exciting developments for the Federal Agency for Medicines and Health Products (FAMHP). You can discover everything in the annual report.

What do you think of a vaccination plan with a genetically modified vaccine against Ebola?

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: important progress in the development of new innovative treatments

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.

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