This year marks our first time exhibiting at the World Drugs Safety Congress EU. With a line-up of stellar speakers and representatives from all major pharma companies, software vendors and consultancies, we enjoyed some lively discussions and insights into the latest trends across drug safety, PV and reporting.
It was great to see some familiar faces from the conference circuit this year and some of our long-standing customers. We’re constantly developing the CARA Life Sciences Platform and looking for exciting innovations to enrich our roadmap; events such as this one give us a chance to get first-hand accounts of the struggles professionals within safety are facing, and see how we can better accommodate for this while preparing for other future challenges.
Here are our key takeaways from the conference and the many interesting topics discussed:
There’s a running theme of connectivity not just within safety but across whole enterprises. Better communication between teams in different countries, across departments and with health authorities allows companies to reduce the time to market, putting the health and safety of patients at the forefront of our industry.
Establishing consistent and clear lines of communication averts issues such as missed deadlines, difficulty in locating correct versions of documents, and unnecessary re-work. One presentation spoke of managing transitions to more digital and streamlined ways of working. Often, information in a safety data base can come from a multitude of different sources with storage in different systems all enveloped in different processes. This lack of traceability means that companies have to manually find information which leads to delays, particularly when business-critical upgrades are needed.
A single platform approach means that all information is organised within one common information lake, making it easier not only for safety teams but also for other departments to access the information they need at the time they need it. Our ‘where used’ feature also received some great feedback as it has wide application for safety processes, you can see how it works here.
There is a need for better, standardised, out-of-the-box systems. Many companies still rely on disparate systems with largely manual processes using systems such as SharePoint and Excel. While this may be sufficient for small teams, they are not scalable and secure enough to meet the needs of established companies. Everyone has the same underlying process they must comply with, yet, whilst all compliant, there is disparity in the approaches used which leads to wasted time and resources. This process is ultimately about patient safety so it should be a priority, but in smaller companies sourcing the financial resources to update and standardise systems can be difficult. Hyper-customisation within projects is not necessarily a good thing and can increase disparity. Multi-tenancy is one recommended solution for this for several reasons:
o Rules can be applied across all tenancy for a more consistent approach
o Sharing of upgrades (resource and cost) e.g. for MedDra upgrades
o Promotes industry standard practice
o Possibility of shared analytics
The CARA Life Sciences Platform offers both single tenancy and multi-tenancy, both of which are scalable. Management of PV, PSMF, SDEAs are just a few of our OOTB solutions, our upcoming webinar will feature a demonstration of these capabilities.
AI and Automation
Year on year we see efforts to increase automation and use more AI within already established processes. Several presentations and roundtables discussed how different leading pharmas are leveraging its power. One example was case processing, AI is playing a key role primarily in minimising effort on cases which do not deliver added value, the x thousandth case of reddening at the injection side for a Covid Vaccination was one common example.
The EU is advancing its AI Good Practices regulations (EU AI Act) but the guidelines are still in a state of flux and it is not yet clear under which circumstances AI handling Safety Information from Pharmacovigilance will be considered ‘high risk’. There are many other areas where we can use automations to make processes more efficient and reduce manual work, one of which is Structured Content Management. With the CARA Life Sciences Platform this is straightforward, you can see more info about this here.
Thank you to the whole Terrapin team for their time and effort in making this an excellent and insightful conference, we really enjoyed participating and already look forward to next year.