This year’s World Drug Safety Congress brought together a stellar line-up of thought leaders and industry experts to discuss an array of hot-topics at this year’s World Drug Safety Congress. Since the boom in tools like ChatGPT, Bard, and other viral AI platforms, many organisations have moved away from the tentative discussions and implementation of AI to truly understanding its wide-reaching impact on the business. So it’s no surprise that AI and Automation, as well as broader Digital Transformation, were the focal point of many conversations and presentations during the event.

Below are some of our key takeaways from 2023’s World Drug Safety Congress



Artificial Intelligence (AI) and Machine Learning (ML) are two technologies leading the charge in innovation across the Life Sciences sector today. One organisation presented a case study on the application of AI and ML early in the PV workflow in order to optimise patient centricity through enhanced Adverse Event (AE) detection.

The presentation highlighted how, even though traditional applications of AI in PV operations begin at the case processing stage once an AE has been discovered, only 1-10% of all Adverse Drug Reactions are reported to the FDA Adverse Event Reporting System (FAERS).

In order to optimise this process and decrease the risk of missed adverse events, the organisation implemented a new initiative which would apply AI and ML earlier in the PV workflow to automate a majority of the reviews, decreasing the chance for human error.  This initiative aimed to make a positive impact to both the patient and the caregiver, as well as downstream to the case processing teams. The upstream impact led to a ‘90% efficiency over human effort in an initial review of digital documents’ resulting in ‘550,000 digital documents identified’ and ‘over 18,000 Adverse Events identified’.

While the initiative is proving an overall success, the organisation noted some obstacles and lessons learned. The agility and level of customisation in technology, as well as system integration capabilities, have the potential to impede efficiency and success if not considered from the outset.

Utilising Data and Technology

Alongside a more committed and deliberate use of AI across business processes, many organisations are beginning to better understand the critical role of proper data management in innovation and process optimisation, and have begun tapping in to that potential with technology. One organisation discussed the implementation of a new system to tackle the challenges associated with Safety Signal Evaluation and Management. This particular organisation highlighted their current landscape; with more than 470 products/medicines both in development and on the market, and over 280,000 Adverse Event reports per year managed, the company found themselves swamped with data that is growing exponentially. As a result, they needed a fast and simple way to generate data to support responses to questions and inspection requests.

The solution was to develop an integrated signal management system to act as a single source of truth, that allows their safety staff to detect, investigate, track, and communicate safety signals and regulatory enquiries, using analytical evidence from multiple data sources.

What the system provided was not only a way to effectively manage an increasing amount of inbound data but also, as the organisation put it, ‘tell a story’ with that data. The system provides an audit trail of all signals and safety topics evaluated, as well as the decision rationale behind each conclusion. The Safety staff using the system also benefited from faster retrieval of signal data for audits/inspections, and a metrics module to enable real time tracking of signal assessments.

What this case study highlighted was that organisations are sat on endless amounts of data brimming with untapped potential. Instead of viewing data as a barrier to efficiency, it should instead be viewed as something to harness; all organisations need is the right technology in place to be able to manage and utilise that data in order to optimise processes.


At Generis, connectivity is our bread and butter, so it was fantastic to hear a couple of presentations touch on the importance of connectivity in an organisation. One such presentation discussed the challenges faced in interactions between the Pharmacovigilance and Regulatory departments. Criticalities identified between the two departments included a lack of clear communication channels, inadequate processes to define responsibilities, conflicting priorities, and insufficient resources.

While the presenter suggested ways in which to optimise Regulatory-PV interaction, e.g. regular meetings to enhance communication, more cross-functional training, and performance monitoring; what resonated the most was the application of shared systems and tools. This was broken down into three stages:




The benefits of a shared system, such as a content and data management system, where both PV and Regulatory teams can access a single source of truth for cross-functional data, are boundless. By breaking down the technological and departmental silos these two domains operate in, teams can access and collaborate on enterprise-wide information and content that is critical to processes on both sides. It gives the ability to reduce duplicative work, avoid version control issues and outdated documentation, improve communication and collaboration, and increase traceability across the business.


A prime example of connectivity in the Safety domain of a Life Science organisation is the Pharmacovigilance Safety Master File (PSMF). The PSMF is a complex ongoing task, between updating sections owned by different parts of the business, and the challenge of creating Annexes from information that comes from a variety of sources; the PSMF requires data and input from multiple domains outside of Safety and PV. Despite this, many organisations still use manual processes and tools like Microsoft Word or Excel to build, maintain, and track the PSMF.

Our CARA Life Sciences Platform customers always emphasise how important it is to them to be able integrate all Safety, Quality, and Regulatory related functions into a single platform, with a single data lake, providing the ability to pull data from multiple sources and reuse it across departments. This level of connectivity enables time-saving automation capabilities, and importantly, the ability to share information and collaborate on content easily.

The need for interdepartmental connectivity does not end with the PSMF however, and often the supporting information is needed elsewhere in your organisation for PSURs or perhaps a PSMF for another product. By harnessing a data-first platform shared by the Safety, Quality and Regulatory functions, the content of the PSMF can be separated in to compartments, allowing for the flexibility of multiple data owners. Users can extract individual compartments from the PSMF for use as standalone documents, or for use in other items in the product development lifecycle.

By removing technological silos, you can break down barriers to that critical communication and collaboration across teams, accelerating processes and providing a far greater accuracy of information.

It was great to join our clients and partners at the WDSC this year. It was a great opportunity to connect with industry professionals and develop a shared goal and understanding of the direction the industry is heading in with the latest innovations in AI, data-centricity, and digitisation across the drug safety landscape.