HALOPV Module: Submission

The HALOPV Submission module - handles a range of important drug safety activities:
- Perform compliant submissions of ICSRs to Regulatory Authorities, in a variety of formats e.g. E2B(R3), E2B(R2), CIOMS for EMA, FDA. Health Canada, MFDS (Korea), etc.
- Submit / receive and track acknowledgements via integrated gateway or via secure links to partners and affiliates.
- Manage submissions of PSURs, device reports such as MIR etc.
- Compliance can be tracked and viewed across all types, and both gateway / manual submissions
- Auto-detect late submissions and enforce a LTI form (Late Task Investigation) to ensure a compliant way of managing deviations
- Integrate with the Requirements Intelligence module to automatically schedule activities and reversely 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
- Integrates bi-laterally with safety databases Argus Safety and ArisG, e.g. submit using the module on cases from another safety database.
-Link to PSMF module, to update Annex F

Go to https://lnkd.in/epzS3X8 to read more!

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