On the 12th of November, ARITHMOS hosted the first annual Pharmacovigilance Day seminar at Hotel Melia in Milan, Italy. The event, supported by Oracle Corporation, was born to discuss changes taking place in the pharmacovigilance environment, including new and and updated legislation by the European Union, and to present new and improved technology solutions to enhance pharmacovigilance management.
ARITHMOS put together a team of expert panel speakers to discuss pharmacovigilance safety databases, data migration, signal detection and regulatory compliance for pharmaceutical, biotechnology and medical device companies as well as CROs of any size. The reality is that many companies, especially of small to mid-size dimension, struggle to implement effective pharmacovigilance processes that both comply with regulations and improve efficiency while keeping costs under control.
Paolo Morelli, ARITHMOS CEO, introduced and moderated the event.
Panel speakers Robbert Van Manen of Oracle and Mike Roberts of Pink Octopus Consulting addressed new pharmacovigilance legislation. Robbert presented the EU’s GVP Module IX on Signal Management and how its requirements can be met with the current release of Oracle Empirica Signal and Topics. Meanwhile, Mike discussed the migration of a pharmacovigilance system to Argus Safety in order to comply with international regulatory standards, improve quality and data standards and positively impact productivity.
Marco Bulleri, representing Abiogen Pharma S.p.A., presented a case study on implementing an Oracle BPO (Business Process Outsourcing) solution for small to mid-size pharmaceutical companies. The case study demonstrated how Abiogen utilized this solution for the collection of safety data coming from both clinical trials and post-market surveillance and the support received by ARITHMOS in migrating and implementing the new AERS system.
Rounding out the expert panel was the team of Gianluigi Albertini and Stefano Piccoli of ARITHMOS who did presentations on cloud technology. The presentations captured both a solution for pharmacovigilance and the adoption of technology trends in the healthcare field. Starting from the definition of “cloud” and SaaS (Software as a Service), Gianluigi demonstrated how current PhV systems such as Oracle AERS and Argus can be delivered as a SaaS solution. In the second presentation, Stefano covered compliance in the cloud including computer system validation solutions.
The seminar, which was conducted in dual language (Italian and English) and free for participants, received positive feedback from all attendees. Overall, participants found the seminar informative and useful for current pharmacovigilance needs and appreciated the chance to discuss and debate these issues in a professional environment.
The event concluded with a cocktail reception offered by ARITHMOS for all attendees.
ARITHMOS is planning to hold the event again in 2014 and add additional seminars on healthcare technology topics.
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