E2B Gateway Speeds AE Submissions to Regulatory Authorities

UBC offers electronic data transfer to FDA

E2B Gateway Speeds AE Submissions to Regulatory Authorities

Pharmacovigilance reporting is governed by a strict timeline.  Unexpected fatal or life-threatening expedited clinical trial individual case safety reports (ICSRs) must be submitted to the FDA and other regulatory authorities as soon as possible, but no later than seven calendar days from the initial receipt of information. Serious reactions that are unexpected events (not documented in the investigator brochure or package insert) must be evaluated and submitted within 15 days.

As manual submission of reports can cause significant bottlenecks (especially during holidays or high volume reporting periods), electronic transfer capabilities are important.

Our Argus Safety Team recently worked with the FDA to implement an E2B Gateway which allows our global safety team to submit ICSRs electronically.  This provides a means of compliant filing which alleviates time pressure, allowing safety scientists and the medical review teams to do what they do best -- evaluate Adverse Event reports. The Pharmacovigilance staff also can process more reports in less time, allowing for increased time for medical review and setting the stage for increased case volume potential.

UBC has validated our database to the E2B data requirements specified by the International Conference on Harmonisation (ICH) and performed successful testing with the FDA. We're also working with the European Medicines Agency as well as the regulatory bodies within various countries within the European Union to meet their criteria for E2B submissions.

The ability to submit ICSRs via the E2B Gateway is great news for our clients, and UBC's Pharmacovigilance global safety team is excited to be on the forefront of streamlined solutions.

For more information about UBC’s new E2B capabilities, please contact us.