23 Countries in 2 months

Complex Local Pharmacovigilance Support

Global consulting company, France
Est: 1997  Size: 51 - 200

arriello_eu countries_header image

Project: Empowering a life sciences organization to successfully implement a local pharmacovigilance system in 23 EU countries.

Summary: Pharmacovigilance, local PV, recruiting and training local contact persons for pharmacovigilance (LPPVs), regulatory strategy, regulatory intelligence

The client had previously partnered with another consulting firm who lacked the organization and expertise to mange this complex project resulting in a failed initiative. During a previous local PV project, Arriello’s faster, better, smarter approach had previously made an impression on this client and they turned to us for support.

Challenges

While the scope of the project was the same, the process would differ for each country, with different requirements and regulations for an LPPV. Not following these guidelines could result in an Authority rejecting the LPPV and losing Marketing Authorization.

Differing country-specific guidelines also made literature screening complex. Helping our client take the smartest route for each country required both indepth knowledge and effective local vendor management, adapting to different processes and conditions whilst remaining under budget and on time.

Solution

We hand-selected LPPVs for each country based on their PV, IT, Quality systems, Project management skills and more. All details of the project were fully assessed for responsibilities, timelines and documentation. LPPVs then notified their local Authorities where needed and we delivered a project management plan detailing everything from our client’s high-level objectives to the roles and responsibilities of project managers team members.

A comprehensive PV manual provided LPPVs with guidance on their responsibilities and all training documents. We ensured that all LPPVs provided full information on project activities in detailed monthly reports.

Our proactive approach meant we went beyond simply managing multiple teams, preparing documents, or LPPVs oversight, we also scanned for information and intelligence that could impact our client such as the latest regulatory requierments, and adapted our services as needed.

Faster. Better. Smarter.

Partnering with Arriello meant our client successfully accomplished its objectives, implementing a local PV network that was faster, better, and smarter.

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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