Toronto, ON, May 2, 2018 (Newswire.com) - In a live presentation upcoming on Friday, May 18, 2018 at 10am EDT (3pm BST/UK), experts from pharmasol will discuss how practitioners can automate complex document distributions to keep all involved parties - including health authorities, central and local ethics committees, investigative sites and the study team - informed about ongoing safety issues of an investigational medicinal product (IMP).
It is a central obligation for the sponsor of a clinical trial to meet national regulations that must be followed when conducting regional and global clinical trials, which differ from region to region and country to country. Viewers will learn how to handle these different requirements by using psiXchange in an elegant and timesaving way in the field of pharmacovigilance.
Featured speakers will provide insights into how:
· Companies automate the distribution and dispatch of suspected unexpected serious adverse reactions (SUSARs) and other safety documents such as development safety update reports (DSURs) and expedited single and periodic safety documents, according to company-specific processes
· Depending on system configuration, submission and oversight can be managed on a product basis and not only on a clinical trial basis, therefore removing the burden to coordinate different teams working on different clinical trials and allows for staff to focus on other more valuable activities
· The tool interfaces with any safety database, accepts documents sent in from any external system or manual upload in any format (e.g. XML, PDF, XLS) and automatically handles specific distribution methods, such as fax, email, courier and E2B
· To overcome many traditional manual obstacles and track progress in real time with a full tracking and audit trail
The webinar will benefit professionals working within drug safety/pharmacovigilance, as well as medical scientific liaison, medical writing, risk management, site management, aggregate reporting, regulatory affairs and clinical operations.
For more information or to join this session visit: An Automated Approach to Global Adverse Event Reporting in Pharmacovigilance.
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