On May 15th EMA has released the revised External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use – Version 1.5. EMA also published an accompanying Summary of changes to the ‘External guidance on the implementation of… read more →
Maxer’s Digital Marketing Team has completed the project on behalf of Biocure to analyse digital behaviours for a group of specialists on a national scale in Italy. The project aims to optimise and make the client company’s medical-scientific information activity more effective. This is done by identifying subgroups of specialists… read more →
In response to the rapid evolution of artificial intelligence (AI) in the life cycle of medicines, EMA has published several documents that illustrate the current situation regarding the role of AI in the development, regulation and safe and effective use of medicines. Based on the documentation developed by EMA, Maxer… read more →
Implementing the EMA User Personas Model for the Clinical Trial Information System (CTIS) project, which Maxer Consulting developed and implemented for Zambon, has been successfully completed. The communication, training, and organisational alignment activities have supported the Zambon departments involved in clinical development in familiarising themselves with the CTIS platform processes… read more →
Chiesi Farmaceutici S.p.A. has assigned Maxer Consulting to implement the 2025 Clinical Trial Disclosure and Data Transparency programme in compliance with the regulations in force in the USA. The CTD/DT activities require that Maxer upload the results of a series of clinical studies to ClinicalTrials.gov Protocol Registration and Result System… read more →
The Maxer Medical Writing team, with the contribution of Annalisa Hinteregger, provided editorial support for the drafting of Integrating the New Pharmacological Standard of Care with Traditional Nutritional Interventions in non-dialysis CKD, an article by Luca De Nicola, Adamasco Cupisti, Claudia D’Alessandro, Loreto Gesualdo, Domenico Santoro, and Vincenzo Bellizzi. The… read more →
Biocure, the Italian branch of the PiLeJe Group, has entrusted Maxer Consulting to implement a project of digital marketing to engage the physicians working within the Italian Medically-Assited Reproduction centres in an educational programme focused on using associated pro-biotics and active substances in addressing successful assisted reproduction. Maxer will also… read more →
On 22 July Massimo Zaninelli, CEO of Maxer Consulting, presented the training session dedicated to “Clinical studies: from submission to AIC” to the young participants of Missione MSL. The lecture outlined the overview of the process that leads from the design of a study to the marketing authorization of the… read more →
