Windhoek: Fruitful Conversations and the Future of Pharmacovigilance in Africa

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The ISoP Africa Chapter Annual Meeting 2026 concluded in Windhoek, Namibia, last week. On my way back home, my mind kept returning to what stood out the most from the meeting. There was so much worth reflecting on: the excellent scientific programme curated by the organising committees, the educational sessions on pharmacovigilance inspection and effective communication in pharmacovigilance, the immense behind-the-scenes effort required to put together an international conference of this scale, and, of course, our gracious Namibian hosts and the beautiful city of Windhoek itself. 

So much to write about! Yet, what I look forward to most at conferences is the people; the opportunity to connect, exchange ideas and engage in meaningful conversations about shared interests. That is what will stay with me the most.

A significant part of my work, as readers of this newsletter would already know, involves pharmacovigilance regulatory intelligence across Africa. This means answering questions on PV guidelines, advising clients on implementation and compliance, and talking to regulatory authorities to clarify vague requirements or those that are simply difficult to navigate. I face enormous challenges every day as in some cases local requirements are not fully aligned with international guidelines. In others, timelines for adverse event reporting are operationally hard to meet, and sometimes responses from regulatory authorities may be slow or altogether unavailable.

What became clear to me in Windhoek, however, is that these issues are widely shared across the industry. Conversations with colleagues revealed a common experience — many of us are facing the same challenges. We were all seeking clarification from representatives of regulatory authorities and advocating for flexibility and harmonisation in PV requirements. But amidst these challenges, I see an opportunity for the industry and regulators to collaborate more closely on the one common goal we all share — patient and drug safety.

There still seems to be significant distance between the two key stakeholders in PV in Africa. Too often, we operate in silos, not fostering enough dialogue and not attempting to understand each other’s operational realities. No doubt the meeting in Windhoek provided a valuable platform for stakeholders’ engagement but these conversations should be happening far more frequently. Industry and regulators need to be sitting in the same room regularly, not only during conferences, but through ongoing collaboration and open communication.

Over a tea break and dinner in Windhoek, I put forward some ideas to colleagues on what this could look like in practice:

• Leveraging any of the several already existing initiatives focused on building the capacity of PV professionals in Africa, such as the Centre of Excellence for Pharmacovigilance in Southern Africa (CEPSA). The gap I have observed is that many of these projects primarily target regulatory authorities, with limited involvement from industry professionals. I shared this perspective with the CEPSA project lead, who was receptive to the idea of engaging the industry more within the project.
• Hosting an annual QPPV meeting. I discussed this idea with the representative of the Rwanda FDA, and he responded positively as well. A forum like this would provide an incredible space for regulators and industry professionals to engage directly. It would help the industry better understand regulatory expectations while giving regulators practical feedback on how guidelines are interpreted and implemented in real-world settings. 
• As I write this newsletter, another idea comes to mind:  introducing either a side event or a pre-conference meeting for regulators and industry stakeholders at the next ISoP Africa Chapter Annual Meeting. It would be an open and honest dialogue between the two parties, aimed at understanding each other’s operational realities, shared objectives and challenges. 

I am also a strong believer in advocacy, and in the important role the industry can play in furthering this cause. Much of the advocacy work on medicines regulation on the continent tends to focus on product access and accelerating approvals while PV gets little to no attention. As I mentioned in a previous edition of this newsletter, we need to be present in the rooms where decisions are being made and resources are being allocated.

Encouragingly, I observed that several topics on PV in the industry were discussed at the meeting in Windhoek, perhaps because there were many industry representatives on the scientific committee of the conference. It reaffirmed the importance of representation and the need to ensure the industry’s voice is always present in all the relevant conversations.

Which is why I was pleased to see the Africa Medicines Agency (AMA)’s recent call for expressions of interest to join its technical committees, including those focused on vigilance. I encourage my industry colleagues to apply and actively contribute to the work of AMA and its member countries.

Talking to regulators in Windhoek also gave me a deeper appreciation of some of the internal challenges many face. One regulatory authority representative shared that his PV guidelines for the industry had remained in draft form for three years because there was no board to approve them. Others explained that limited staffing made it difficult to evaluate aggregate safety reports or conduct inspections effectively. Strengthening PV systems as a whole would ensure that regulatory authorities, too, have the resources in their PV departments and the capacity to fulfil their responsibilities as well. 

Ultimately, the conversations I had in Windhoek reminded me that despite the many challenges we face in pharmacovigilance in Africa, there is also a strong willingness among stakeholders to collaborate and improve. Industry and regulators ultimately share the same goal: protecting patients and ensuring medicines are safe. If we continue creating spaces for honest dialogue, mutual understanding, and advocacy, we can build a stronger and more harmonised PV system across the continent. Change may take time, but it is possible when we work together.

Written by

Odokonyero Kennedy

Pharmacist, Global Shaper at Kampala Hub and student of Msc. Pharmaceuticals and Health Supplies Management at Makerere University. [email protected]

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