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Heads of Medicines Agencies statement of intent related to the replacement of electronic application form by the Common European Single Submission Portal (CESSP).

The Heads of Medicines Agencies (HMA) has published a statement of intent related to the replacement of the eAFs by the CESSP. As outlined in the eSubmission Roadmap, the current Common European Submission Platform (CESP) and the EMA eSubmission Gateway will be integrated into a Single Submission Portal. This single portal shall be built on the current CESP. This future system is meanwhile referred to as the Common European Single Submission Portal (CESSP). It’s also envisaged to integrate the current content of the electronic Application Forms (eAFs) in the Single Submission Portal. The HMA statement can be found here .

19 December 2016: final date for submitting dossiers during the Christmas holidays

During the Christmas holidays, famhp will be closed from Monday 26 December 2016 until Friday 30 December 2016 included.

Workshop “Famhp & EMA initiatives to support innovative drug development: implementation of a National Innovation Office as part of the EU Innovation Network

The unit Scientific-Technical Advice & Knowledge Management has the pleasure to invite all those who are interested to the morning workshop “Famhp & EMA initiatives to support innovative drug development: implementation of a National Innovation Office as part of the EU Innovation Network” organised by the federal agency for medicines & healthcare products (famhp) on Thursday 01/12/2016. This interactive workshop will be held at famhp’s offices in Brussels and is free of charge..

Implementation of the National Innovation Office at famhp: consultation procedure

The federal agency for medicines and healthcare products (famhp) prepares the implementation of a National Innovation Office in order to promote and facilitate the research and development of new innovative medecines in Belgium. In this context famhp has developed a questionnaire, in order to fine-tune famhp’s current plans for implementing a National Innovation Office and to align the objectives of the Innovation Office to the current and future needs of SME’s and academia.

Famhp publishes annual report 2015

The federal agency for medicines and health products (famhp) published its annual report 2015.

Workshop “National & EU scientific regulatory support mechanisms and initiatives for innovation in drug development"

The unit Scientific-Technical Advice & Knowledge Management has the pleasure to invite all those who are interested to the afternoon workshop “National & EU scientific regulatory support mechanisms and initiatives for innovation in drug development” organised by the federal agency for medicines & healthcare products (famhp) on Monday 02/05/2016.

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