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Enhancing Pharmacovigilance Efficiency and Cost-Savings at the Local Affiliate Level
At the local affiliate level, maintaining compliant PV and MI models entails a wide variety of requisites
Feb 03, 2023
| Across the fields of pharmacovigilance (PV) and medical information (MI), companies must continuously evolve to accommodate the latest technology and meet the newest regulations across each country where they manufacture and sell products. At the local affiliate level, maintaining compliant PV and MI models entails a wide variety of requisites, including the following: |  |
- Unique local regulatory reporting requirements
- Local language support and/or a local qualified person for pharmacovigilance (QPPV)
- Ensured data privacy and protection
- Local literature review and aggregate reporting
- Sufficient call center services to field adverse event intake
Throughout these processes, it is crucial to maintain consistency and transparency between local and global outfits, particularly when it comes to training and documentation. So how does one ensure these processes run efficiently and compliantly while still managing to reduce costs?
How to Revitalize Your Approach to Local PV
Luckily, there are plenty of innovations that can help bolster smooth collaboration between the global and local level, ensure consistency across affiliates, increase cost savings, improve patient safety, and alleviate high volume strain on local PV teams. A number of these solutions are offered as part of IQVIA’s Local Affiliate Product Services (LAPS):
- A QPPV who speaks the local language and can engage with regulatory authorities and portals
- A regulatory intelligence database (RID) that provides high-quality insight into PV reporting expectations
- Translation technology to help support local literature review
- Individual Case Safety Report (ICSR) management with 50 different languages supported for direct language translation of adverse events (AE)
- A combined human and AI call center service model to help field product information requests and AE intake while providing support during volume surges
Where to Learn More
In the recent whitepaper, “Thinking globally, while acting locally – How to streamline pharmacovigilance and medical information at the affiliate level,” IQVIA leaders, Alisa Hummings, senior director and head of medical information and CEVA services, and Barry Mulchrone, senior director and head of pharmacovigilance oversight and analytics, provide their expert insight into local PV, MI, and risk management challenges and solutions, including those offered as part of the LAPS offering. To learn more about how your PV model can reduce costs and better ensure patient safety, download IQVIA’s comprehensive whitepaper.