EU expertise delivers results

EU Pharmacovigilance system and Regulatory Support.

Global Pharmaceutical Generic, Canada
Est: 1983  Size: 1,600

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Project: A fully outsourced EU Pharmacovigilance system.

Summary: The client chose Arriello to be their outsource partner for all of their EU Pharmacovigilance activities, both local and global.

This Canadian client, a leading generic pharmaceutical company, was successful in their national market but wanted to expand into Europe. Building an in-house EU Pharmacovigilance System would have required a significant financial investment alongside risk, so they chose Arriello as their partner to deliver a fully tailored system saving cost, time and minimizing risk.

Challenges

The client had limited knowledge of the European Pharmacovigilance framework and was completely reliant upon Arriello's guidance at every stage. This meant that Arriello's trademark strengths in commercial approach, communications and technical knowledge were crucial to gain the client's trust and confidence throughout the process.

Solution

The first step involved extensive consultation with the client on current and future EU requirements to enable their resource and budget planning. Secondly, a thorough training program covering the key aspects of Pharmacovigilance in Europe ensured that the client, as the Marketing Authorization Holder (MAH), fully understood what their responsibilities would be.

We also provided consultative advice for some of the client's products where local requirements differed between countries.

Faster. Better. Smarter.

The client had no prior experience of the complexities of EU Pharmacovigilance requirements but needed to ensure they were fully compliant with them. Through our faster, better, smarter approach, Arriello provided all the reassurance necessary that the entire process would be managed effectively and currently continues to manage all of the client's EU PHV requirements.

In addition, Arriello reduced risk for the client through Regulatory Support as a core part of the solution, allowing us to demonstrate our in-depth understanding of managing the complete regulatory and vigilance life-cycle, and our commitment to them as a trusted partner. This resulted in a successful European Health Agency inspection in January 2016. .

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