Will your safety system be compliant with regulatory changes?
Keeping pace with new and ongoing regulatory authority compliance requirements is a challenge for even the most sophisticated PV teams in the industry. Fortunately, IQVIA’s Pharmacovigilance experts have solutions that are pre-developed and can be implemented WITHOUT the need for a costly and burdensome Argus upgrade.
If your company is considering how to address one of the following, please consider IQVIA’s solution(s) as a rapid response for complete compliance:
- FDA R3 support with automations and configuration of many fields to reduce case processing time
- Map EDQM doses and formulations with multiple levels of specificity built in
- Local Language and Direct regulatory authority submissions for China, Korea and Latin America countries
- Local languages built in
- Eliminate the need for local affiliates and the re-key/re-process requirements
- Automate the WHO MPID mapping for reporting to various authorities
As standalone solutions, or combined with IQVIA’s existing automations for Argus, including Auto Null flavors / Auto Follow up
iNarrative (English, Japanese, Chinese) Auto Seriousness and Auto Listedness, your PV organization can stay focused on higher value use of time and ensure compliance.
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