ARITHMOS, with the support of Oracle, is hosting the first annual Pharmacovigilance Day this autumn to address the challenges of pharmacovigilance for pharmaceutical, biotech and medical device companies as well as CROs. This event is a workshop on modern pharmacovigilance technology solutions concerning both European Union regulations and improving operational efficiency for pharmacovigilance management processes.
The workshop is taking place on Tuesday, 12th of November in Milan, Italy. This event is free of charge but limited seats are available, and the expert panel will present in both Italian and English.
Why a focus on Pharmacovigilance?
The European Union and the European Medicines Agency (EMA) have taken steps to improve patient safety in clinical trials based on the startling fact that 200,000 patients die each year from Adverse Drug Reactions. Companies are faced with the challenge of finding solutions that can improve the quality and analysis of safety data while managing the increase in quality of data and the need to satisfy regulatory requirements.
The latest pharmacovigilance regulations – known as Good Pharmacovigilance Practice (GVP) – went into effect in 2012 in order to better analyze and understand data from clinical studies, especially post-market studies, to identify risks to patients. More recently, the EMA has released guidelines for complying with ICH E2B (R3) which regulates electronic transmission of individual case safety reports (ICSRs). Due to the increased regulation on safety data and the need to improve data quality, pharmacovigilance becomes very data intensive and difficult to manage.
The workshop features a panel of experts who will discuss the implementation of technology solutions for meeting the following challenges:
- Pharmacovigilance Regulations
- Pharmacovigilance Databases
- Cloud-based solutions for Pharmacovigilance
- Safety Data Migration
- Regulatory and Customized Reporting
- Signal Detection
Workshop speakers include experts on pharmacovigilance systems including Robbert van Manen of Oracle, Mike Roberts, an Argus Safety expert from Pink Octopus Consulting, Marco Bulleri of Abiogen and Gianluigi Albertini and Stefano Piccoli of ARITHMOS who will do a joint presentation on leveraging cloud technology in pharmacovigilance and the challenges of compliance.
To read presentation abstracts and the biographies of the presenters, visit the Pharmacovigilance Day website:
For more information on the event including registration, follow the links below: