Experiences from speaking at the DIA USA in June 2017; read about the challenges of a global pharmacovigilance system and strategies to manage it.
Speaking at the DIA
During the DIA USA in June 2017, I was one of the three speakers in the session: The Brave New World; The Ongoing globalisation of Pharmacovigilance (#320). The main topic of this session was how to manage a global Pharmacovigilance system. My specific contribution was sharing my experiences with growing pharmaceutical companies whose growth strategy was: entering the European Market.
Growing EU Market
The EU market is estimated to grow to a staggering 206 billion Euro in 2022. Whether the growth of a company (and thus sales) is achieved by establishing affiliates in Europe, entering into commercial partnerships (distribution or license partners), or acquiring local companies, there is always an impact on the company’s current PV system. Changes (or upgrades) of a PV system are inevitable and need to be managed with care to avoid non-compliance with applicable regulations at any given time. This is especially challenging in the EU where regulations are among the most conservative. Particularly the requirements to have only one global PV system while working in different global environments and thus having different regulatory requirements all applicable to that one PV system. Next to that, the PV system needs to be managed by different people with their own cultural habits and languages. So how do we manage these challenges?
"Plans are nothing; planning is everything." Dwight D. Eisenhower
Experiences / Pitfalls
During my presentation I shared some pitfalls for each strategy from my personal experiences:
- For example, an acquired company’s product portfolio can be so different, that their PV system is not able to handle a new innovative product with events under special monitoring in combination with a higher case load. The impact of the different product portfolios is often not recognised during due diligence because Subject Matter Experts for PV aren’t involved.
- Another example is the incomplete merger of two PV systems, resulting in PV staff working according to different standards, which leads to compliance and data integrity problems as well as a lot of duplication of work.
- Or a partner that turns out not to be as compliant as had been indicated during a qualification audit. It’s questionable how this is possible, as this should be exactly why you perform an audit in the first place. If the audit isn’t executed by experienced staff with access to the right background information the audit becomes a tick box activity and you may be in for a surprise.
- Establishing new affiliates has its challenges, as many different priorities need to be addressed during the pioneering phase in which contractors and vendors may be used for PV system related tasks. The big questions here are: do these vendors/contractors deliver and does the staff at Head Quarters truly understand the local (EU) requirements of a compliant PV system?
4 Recommended Strategies
The three session presenters, independently from each other, came to the same conclusion on how to establish and maintain oversight on a global compliant PV system:
- Have a strategic goal/objective at the level of the company’s (Senior) Management: decide on a company’s goal and the route to obtain this goal. Ensure that everybody is informed on the growth strategy and understands where the company is going. For example, the company will be expanding its market into the EEA and to ensure a fast submission of the dossier, obtain approval, and launch the product, a fully functioning EU compliant PV system is a prerequisite.
- Implement a governance structure to manage changes and monitor the performance of the PV system throughout the transition phase. Project management principles must be implemented through comprehensive plans with explicit timelines. Ensure PV contracts, describing who is responsible for what, when and decision-making PV committees with binding charters, supplemented with global SOPs describing how tasks are executed and against what standards, are implemented.
Following the above strategy, a vendor needs to be selected and qualified before work can be delegated. Delegating the work to a vendor means that the contractor remains responsible, so you need to “check” your vendor’s performance. Preferably in real-time and not 3 years later during an audit. Therefore, the company needs to set up a performance monitoring platform and agree on how often to measure, what to measure against (KPI), and decide on who takes the decisions. What can be decided without escalation (and what not – meaning scope and boundaries), how to monitor their performance during the project, and, most importantly, against which standards the work should be executed (e.g the GVP guidelines) should be part of the contract. This also implies that although the work is carried out by the vendor, resources are required to manage the oversight.
- Before any work or responsibilities are delegated, due diligence or qualification audits need to be executed by experienced staff who understands the impact of the planned changes for the PV system.
It sounds a bit strange in a GxP environment, but do ensure that the team members involved in the Due Diligence or qualification audits are actually qualified for the job. And if this is not the case, you should add a subject matter expert to the team. For such important tasks, you may expect that at least one person with work experience in PV is involved. When the PV requirements become a checklist, the “tick boxing audit” may turn out to become a nasty surprise. Such as: “yes, there is a safety database”, but it turns out, the system is not validated and there is no E2B reporting in place. With a few hundred cases per month or even less, this is definitely not a nice surprise.
- Plan your activities by ensuring a structure is in place, resources and budgets are assigned and timelines (deliverables) are communicated and agreed upon.
Let me also share the most important lessons learned over the past years: with the implementation of the new PV guidelines in 2012, the PV system interacts with roles and responsibilities from many departments throughout a company and having them “on board” from the early beginning is a challenge, which, if managed correctly will pay off. The solution to managing those involved from different departments lies not within the PV department or within the PV system alone. Having Project Management in place, ensuring these cross-divisional structures, is equally important.
With this strategic approach, any company will be more likely to remain compliant during important changes and enabled to act on deviations more rapidly. All it needs now is the human touch.
Blog by: Sandra van der Poel - Principal Consultant Pharmacovigilance