ICSRs, local literature screening, PV manual and training, regulatory intelligence, safety mailboxes.

Strategic planning
for effective results.

Client type.

Pharmaceutical.

Geography.

European Union.

Lifecycle stage.

Post-marketing.

Service area.

Pharmacovigilance.

Summary.

  • ICSRs, local literature screening, PV manual and training, regulatory intelligence, safety mailboxes.

  • Having established its worldwide product in several international markets, this Danish pharmaceutical company was conducting in-house pharmacovigilance (PV) in LATAM, the EU, and Canada – a total of 50 countries.

  • After shifting its approach to outsourcing, the organization decided to transfer its PV activities to Arriello.

Challenges.

Our client faced a tight timeline. Additionally, a scope of 50 countries meant that clear communication required working around differences such as time, language, culture, ways of doing business, and local regulations. Collaborating with vendors was also a challenge. Each vendor followed its own system, and we would need to align vendors to a common goal, ensuring compliance and effective management to meet the deadlines.

Solution.

Our first step was identifying a LCPPV for each country, screening candidates with a qualification process. After preauditing potential LPPVs, we gave them a questionnaire and evaluated their curriculum vitae. Candidates’ quality management systems, pharmacovigilance systems, experience, and expertise also came under our scrutiny. After a kickoff meeting, we introduced the LPPVs to a PV manual we created exclusively for their support and provided kick-off. This detailed manual empowered our LPPVs with instructions on what, how, and where to report safety information.

Our client’s local PV system also included local literature screening. If new safety information or adverse events were detected, our client would quickly receive a report. Local ICSR case processing was another way we helped our client mitigate risk. Each country accessed the PV safety mailbox including important ICSR findings in a monthly report for our client to follow up on.

Our local PV services would not have been complete without regulatory intelligence, compiled in a monthly report to keep our client up to date. If the information was urgent, our client would receive an alert within one business day.

Faster. Better. Smarter.

By the end of the project, we complied with our client’s requirements and delivered a comprehensive local PV network for 50 countries in nine months when it should have taken over a year. Despite the urgent deadlines our client realized full implementation without encountering major obstacles.

Faster meant the entire process only took about two months. Arriello’s collective expertise expedited the LPPV recruitment and training process as well as other goals. But our speed didn’t compromise quality, the client’s local PV network stayed fully compliant with EMA requirements.

Better meant our client enjoyed a process marked by communication and collaboration. The Arriello team’s project management skills ensured we successfully met deadlines, effectively managed vendors, and established a wide-reaching local PV network.

Smarter meant we took the best strategic route for our client. Leveraging an adaptable, proactive approach to regulations, laws, and updates, we empowered our client to avoid pitfall.

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