SUBMISSIONS TO AUTHORITIES AND PARTNERS – MANAGING DIVERSIFIED GLOBAL DISTRIBUTIONS
Manage compliance of all submissions via submission records. Manual submissions are managed in separate workflow, but compliance can be viewed, e.g. across all ICSRs, device reports, PSURs etc.
Auto-detects late submissions and enforces a LTI form (Late Task Investigation) to ensure a compliant way of managing deviations
Link to requirements, use requirements to schedule activities and reversely i.e. track the number of actual submissions sent out based on requirements
The Submissions overview screen allows for setting search parameters and filter for charting, tables and details for submissions to specific reporting destinations or per destination type e.g. Ethics Committees
Integrates with major safety databases Argus Safety and ArisG, to allow for automatic creation of submission records in HALOPV. Or can be used together with the HALOPV module “Requirements Intelligence”
-Link to PSMF module, to update Annex F
Submissions at a glance
HALOPV offers a comprehensive approach to scheduling, generating, distributing and tracking submissions. The module includes an integration to the Requirements Intelligence module that allows for intelligent auto-scheduling to any agency or partner that have reporting rules setup.
Submissions includes formats to stay in compliance e.g. E2B(R2), E2B(R3). and CIOMS. A unique feature of the module is the ability to track receipt even though the distribution is a CIOMS or aggregate reporting, making it very suitable for Investigator and EC notifications of SUSARs
ENSURE END-TO END SUBMISSION TRACKING / COMPLIANCE
Global Pharmacovigilance (PV) submissions are generally divided into ICSRs and aggregate/periodic reporting. PV submissions are increasingly done in electronic, XML based formats, across the board, not least due to the work of setting global reporting standards by the ISO and ICH. Electronic reports submitted in English are typically being handled by a central function at HQ and can to a large degree be automated via well known techniques and distributed via gateways, if the submission volumes deem this necessary.
Unfortunately, not all submissions can be handled that way; about 40% of all ICSRs across global industry are rendered out as structured forms and need manual submission to an Authority or partner. In some of these cases, the information needs to be translated to local language first. Hence, it is a large undertaking for most companies. Considering any type of PV submissions, the problems becomes a challenge of understanding whether all the distributions were in fact done according to the requirement. If a report was not done submitted timely, consequences are typically to raise a form of non-conformity, to document that a compliance breach happened and also the reason for it.
Many companies have setup complex methods for doing monthly compliance checks of ICSR submissions and ensuring that appropriate non-conformities have been raised. The method we typically see are spreadsheets that are emailed to affiliates and partners.
The task to consolidate and reconcile the data becomes a significant task at central level.
Regarding periodic report submission, the landscape looks slightly different than ICSRs - Regulatory Affairs (RA) units are often responsible for the submission task, after receiving the final document from PV. Often the tools that are utilized by RA are not tightly integrated with PV tools, and the end-to-end process overview therefore becomes cumbersome to generate.
Knowing the importance of being able to ensure end-to end submission tracking / compliance, we have invested in making a PV tool that improves this process across local and global activities. It is called HALOPV.