PharSafer Processing of ICSRs and SUSARs

PharSafer has been reporting electronically for clients since January 2008, processing both ICSRs and SUSARs in Europe (EMEA) as well as with the FDA in the USA. Over this time we have tested with all of the Regulatory Agencies capable of reporting electronically using EVWeb technology as well as Gateway requirements and have extensive knowledge of setting up clients for electronic reporting using cost effective models and documented procedures for the set up and processing of such events.

Additionally, PharSafer has been working with clients using the Eudravigilance Medicinal Product Dictionary Database (EVMPD) for the registration of Company products using the Eudravigilance guidelines, helping Companies remain compliant.

ADR Expedited Reporting; Periodic Reporting & PharSafer

A recent review of our activities has revealed that in addition to the usual ADR reporting that we are doing to the FDA; EMEA; Canada and Japan, we are currently reporting ADRs in total to over 50 countries  – thankfully with our up to date knowledge and safety reporting plans, this is very manageable for clients, but with growing and emerging markets this area continues to keep us on our toes for ensuring compliant reporting – since not every country wants the same thing – variables such as time; language; format; paper/electronic; serious or non-serious; expected or unexpected; healthcare professional or consumer; local cases versus foreign reports all add to the complexity in remaining compliant to the legislation.

The same is true for expedited reporting in clinical trials where currently we are reporting to over 25 countriesin clinical trials again with differing requirements, timelines, formats etc…

Equally, for PSURs and PAEDRs (USA Periodic Reports), the list is equally impressive with over 50such reports going out worldwide. Again, these are different formats, timelines, content, and even within the EU there are local differences and requirements concerning formats and delivery including up front charges!

Our experience in this area means that clients can be assured of the correct information reaching the Regulatory Authorities in the required timelines.