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 →
With the kickoff meeting on March 4th, Zambon S.p.A. started the implementation of the “EMA User Personas Model for the CTIS” project, the organization of which is entrusted to Maxer Consulting. The project, with its focus on communication, training, and organizational alignment activities, is designed to prepare Zambon to manage… read more →
On October 13, Massimo Zaninelli held the lecture Introduction to EMA Clinical Trial Information System (CTIS) at the two-year Master on Regulatory Discipline “G. Benzi” – University of Pavia. CTIS serves to implement EU pharmaceutical law in the Clinical Trials Regulation (Regulation (EU) No 536/2014) and supports the flow of information between clinical trial… read more →
As part of the 2023 consultancy activities on Clinical Trial Disclosure and Data Transparency, Zambon S.p.A. asked Maxer to provide the course entitled “ClinicalTrials.gov and CT.gov PRS Modernization”. The course, held on 23 April, touched on the following topics: Modernization of ClinicalTrials.gov Beta version update process Beta versions of ClinicalTrials.gov… read more →
On November 21, Erika Ornago and Massimo Zaninelli created the training program dedicated to the EMA Clinical Trials Information System (CTIS) and the User Personas model for the Clinical Operation Team of Erydel S.p.A. The first part of the course summarized some concepts and processes of CTIS, while the second part… read more →
On November 2 and 4, Erika Ornago and Massimo Zaninelli held the training course dedicated to the CTIS User Personas model for the Clinical Operation Team of Italfarmaco S.p.A. The two four-hour sessions each focused on defining the organizational model to support the EMA Clinical Trials Information System. CTIS involves… read more →
Maxer has implemented a programme to help commercial and non-commercial clinical trial sponsors get accustomed to the EMA Clinical Trial Information System (CTIS).and The programme also supports the update of the sponsor’ organisation models to the CTIS requirements. The programme includes two training sessions– the first is dedicated to… read more →
On 28 and 29 June, Erika Ornago and Massimo Zaninelli (Maxer Consulting) performed for Dompé S.p.A. the “Working with CTIS” training programme, which focuses on the EMA clinical trial information system. The Clinical Operations and Regulatory Affairs teams of Dompé participated in the two sessions. The participants fueled a lively debate on critical… read more →
On March 30th and 31st, Maxer provided the training course “Working with the Clinical Trial Information System” to the Zambon Group Clinical Operations team. The over fifty participants made the course interactive thanks to the many questions asked. The main objective of this course was to support the participants in… read more →
We are pleased to announce that Dompé S.p.A. has entrusted Maxer Consulting with implementing the Clinical Trial Disclosure (CTD) programme and consulting to implement the EMA Clinical Trial Information System (CTIS) in its organization for 2022. CTD’s activities require Maxer to ensure compliance by Dompé with the regulations in force… read more →
