EIPG Newsletter

After the recent General Assembly, the new EIPG Draft Code of Practice for Qualified Persons has been published in the Members Area of the association's website. The EU Commission released updates to EudraLex vol. 2A and 2C. News on reporting and communication on medicines shortages and open consultations

EMA’s Board meeting in June 2019 still delayed many regulatory activities due to an estimated 20-25% loss of staff after the move to Amsterdam. Transfer of MAs from UK to EU-27 countries is almost completed in preparation to the Brexit, and some additional workload came also from the entry in force of other pieces of European legislation

Keytruda is expected to replace Humira as the top selling drug by 2024, according to a report from EvaluatePharma. R&D investments should reduce, while 400 new products should exit pipelines, mainly in the immune-oncology and orphan diseases areas

Hundred breakthrough technologies might revolutionise the current model of society in twenty years' time, says a strategical report from the European Commission. Radical innovation should occur also at the social level, and global value networks are expected to become the reference points for prioritisation of activities and communication and decision-making

More than 1,300 professionals from the pharmaceutical industry and 100 sponsors attended the annual meeting of the Associazione Farmaceutici Industria. The debate was centred this year on challenges to be addressed to face the new wave of innovation and globalisation in the sector of life sciences

Many themes regarding industrial pharmacists have been addressed by delegates during the 2019 EIPG General Assembly, from education to the role of QP, to issues posed by the coming into force of the FMD legislation. Claude Farrugia has been re-elected as EIPG president for a second three-years mandate

A step forward towards the target of improving transparency on princing of healthcare products and R&D costs, even if the resolution is just a declaration of principle and its adoption remains voluntarily for member states and companies. In the meanwhile, AveXis' product to treat spinal muscular atrophy has been approved at a price of $2,1 million for single treatment, making it the most costly medicinal product on the market

Many new competencies may be relevant for the work of industrial pharmacists up to 2025. EIPG Advisory Group discussed them during the 2019 General Assembly of the association. Updates on open calls for consultation and coming into effect guidelines

Companies working at the development of new anti-microbial treatments can now access early dialogue with the EMA's Innovation Task Force in order to optimise and boost availability of new options. A report by the Inter-Agency Coordination Group of the WHO warns about the possible increase of deaths in future years in case of no action

The network include many different competences and aims to provide consultancy to the European Commision and companies - mainly SMEs - on EU projects management, IP protection and opportunities to obtain investments