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The Change Imperative: Finding the right balance as times change

Posted on March 27th, 2017 by in Pharmacovigilance


I was delighted to chair a CPD Pharmacovigilance meeting last week in Berlin. I had been asked to share perspectives from the discussions within the Pharmaceutical Special Interest group at the Chartered Institute of Ergonomics and Human Factors. Some of the themes we have been discussing have been how to redefine the system involving the medicines development life cycle and the development of human-centred organizations. These topics seemed to fit well within the context of pharmacovigilance, so I was more than happy to accept. Just before the meeting took place, I was asked if I could chair one of the meeting days, and I gladly agreed.

In today’s busy world, there is often a dilemma regarding how to spend time and energy. I know that I and many of my colleagues describe ourselves as “time poor”. This is an interesting development in the world of labor-saving devices. It is a recurring feature of working life, how to ensure both the quality of the work I do and to maintain some time for recovery and further learning. I would have been more than happy to attend half a day of the symposium and listen to one or two presentations. However, as I was asked to chair the meeting, it had quite a shift on the mental space I made for the day. I still had some competing priorities I had to deal with. However, as chair, I became curious about all the presentations and set some time for learning.

There were several themes that were discussed at the event that included the impact of the impending Brexit on pharmacovigilance in Europe. Rudi Scheerlinck gave an insightful presentation outlining the range of uncertainties faced by the community over the next couple of years. This will potentially impact a wide range of activities within the quality organizations, and the changes will take some time to work out completely. For example, the European Medicines Agency is currently based in London, with high numbers of employees from the rest of the EU. The agency has significant numbers of the management positions occupied by UK nationals. The organizational change that is likely to occur is certainly not to be underestimated, and careful thought will need to be given to the transition plan.

Most organizational change I have experienced tries to structure the change and build incrementally. Change can still happen quickly with this approach, but with Brexit there is a chance that the Big 3 areas of what is done, who does it and where the work is conducted will change all at time same time. I imagine the timeline for this change will be a critical driver for how the plan will be executed. The EU is not readily known for the speed at which policy is changed, so hopefully there will be a steady transition of responsibilities and ways to keep and retain staff during this time.

The full impact of these changes on small, medium and large companies was also highlighted. Companies planning for clinical trial initiations and market authorizations will need to have some contingency plans. The UK is a major leader in bringing clinical research into market authorization and decisions on what will need to be done will be made. In my experience, the planning stage usually occurs well before anything is done and it is likely that companies are already needing to make decisions on strategy and tactics.

Several other topics were covered, including describing best practice, sharing experiences in pharmacovigilance, information management and post-market trials in the real-world setting. Change and development of new practices based on the changing needs of patients, regulators and suppliers was a constant theme. One statement that stuck was that people and organizations sometimes do too much pharmacovigilance and sometimes not enough. The challenge we all face in times of change is trying to get it just right—this is the Change Imperative.

To find the right balance, it is important to keep a view of operationally what is happening on a day-to-day basis and what needs to be done to align the operational activities to the overall strategic goals. It also requires transparent risk planning and a dialogue between stakeholders to ensure appropriate learning and their subsequent implementation. Getting it just right also reminds me of the fable of Goldilocks and the three bears. There may be many different interpretations of this fable, and I am sure they have changed over the years. However, my take on this is that even when we do get it just right, there is no time to sleep. We need to keep vigilant and find ways to recover and maintain high performance.

My learning from the CPD event? Listening to others’ experiences again confirms the importance of taking a pause in not only building learning and insight, but also in recharging your own batteries. When I make space for this to happen, it is a great benefit. The second learning is like many other areas in Pharmaceutical R&D—uncertainty is certain for pharmacovigilance professionals.

Finding the right balance is the imperative for managing successful change.

For more information on how to streamline the process and ease the pain of Pharmacovigilance read this white paper.


All opinions shared in this post are the author’s own.

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