Managing Compliance in Pharmacovigilance Partnerships

At a roundtable we recently facilitated on the topic of managing PV partners and associated agreements, we discussed with industry experts the best practices and lessons learned. This topic was fresh on all of our minds, particularly in a year where remote coordination was mission critical.

Managing Decentralized PV Organizations

The first area of focus for the discussion centered on managing PV information flow to and from various partners. Global Organizations rely on a complex network of Business Partners, Affiliates, Local Safety Officers (LSO) and more to manage patient safety activities across all marketing countries and regions. While these PV participants are invaluable to the organization, keeping all parties up-to-date and compliant can be difficult to achieve and even more difficult to document for audits and inspections.

For a long time, keeping a closely centralized team was the best way to mitigate local variations and deviations from the company’s core strategy and operating procedures. This meant that companies would rely on a centralized Global PV team, with limited and very controlled contributions from partners and affiliates. Our experts agreed that this is changing. While the centralized Global PV team still manages global strategy and oversees execution, teams are quickly learning the value of leveraging local expertise at the regional and country level. The industry is moving to a de-centralized model for managing post-marketing safety obligations across processes, including Adverse Event Reporting, Aggregate Safety Reporting, Risk Management, Signaling and more.

With improved tools to provide guidance and support to partners and affiliates, there have been strides in increasing responsibility and input from local teams. These local parties are heavily involved in the collection of information and are increasingly becoming subject matter experts in their own right, especially when it comes to local regulations, standards and cultural norms. The increasing role of local teams, combined with the improved tools available to support de-centralized management efforts, has allowed Global PV to take more of an oversight role.

Engaging Partners to Improve Global Compliance

Due to the large number of Business Partners and affiliates that Global PV must oversee, ensuring that each participant has committed to the overall process can be a daunting task. Achieving “buy-in” from partners on both process and technology is the best way to streamline global operations, improve compliance and ensure that oversight is complete and accurate.  When it comes to effective engagement with individual partners, one of the overarching challenges stems from a lack of standard processes and systems.

A dynamic and intuitive technology is essential to providing a standard platform that every partner can interact through- technology that supports the core business goals while providing a simpler experience for the Business Partner is the best way to ensure system adoption. Technology must allow for alignment with Global and Local processes and provide quality and compliance oversight.

In addition to adopting technology solutions, the Global PV Team must put internal processes in place to ensure the early and ongoing success of the Global PV participants. This includes creating SOPs that lay out expected system use, a clear onboarding process and training materials.

Supporting your PV Processes

What about managing the documents themselves – distribution, updates, and revisions? That is another area where a robust system like Orbit proves invaluable: ensuring that deadlines are met, and appropriate resources are assigned. The system automates tracking and tasking for documents and milestones, and guarantees proper access and permissions for the various global and local users, and is flexible enough to accommodate scope changes when they occur. Orbit is also a validated system, so when it comes times for audits and inspections, it is easy to demonstrate compliance.

In summary, an effective system to support PV Partnership agreement and relationships is one that enables Partners to follow the process effectively while providing global oversight to ensure quality and compliance. To-date, many companies have been relying on a combination of manual systems, such as spreadsheets and email, to track their Partner agreements, but by using Orbit an increasing number of PV experts are finding there is a better way. To learn more about Orbit’s solutions to support PVA and SDEA compliance, you can access our webinar on PVA Compliance solutions here.