Adis Pharmacovigilance attended the World Drug Safety Congress in Amsterdam on Sept 10th and 11th.

The event has been running for over a decade and is world renowned for its ability to connect key stakeholders in the drug safety field, as well as for leading the way in moving the sector forward.

Senior level drug safety professionals, as well as representatives from sponsors and service providers, met to discuss key topics and showcase solutions.

This year’s theme, Addressing Key Challenges for Safety Professionals, had us prepared for a series of interesting presentations and discussions on the ever growing importance of pharmacovigilance and the challenges connected with ensuring patient safety.

The agenda for Day 1 included traditional talks on risk management, regulations, signal detection, among others, but it also focused on emerging topics like the impact of Brexit, how to effectively manage the outsourcing of pharmacovigilance services, big data management in drug safety and new data sources – also tapping into Artificial Intelligence and automation. Day 2 included streams on device and vaccine safety, as well as talks on Real World Evidence in support of pharmacovigilance and patient safety. Both days saw participants take part in interesting roundtable discussions and pre-planned meetings.

The opening talk, Innovation in Pharmacovigilance by Dr Felix Arellano (Head of Product Development Safety Risk Management –F. Hoffmann- La Roche), immediately set out the impending needs in the field, starting from the need for more and better PV due to the accelerated development pathways of medicines. Since many drugs are being approved through targeted and more efficient trials, this in turn leads to less patients being exposed to the medicine. Dr Arellano went on to exploring novel concepts that may revolutionize the way we look at and do pharmacovigilance in the future. Among these, it’s worth to mention the use of predictive safety biomarkers and the expanded knowledge on genetic susceptibility to medicines. These are early steps towards more personalised medicine and healthcare, where side effects can be avoided or at least largely limited by bringing together what we know about individual differences, so that the right patient receives the right drug at the right time. The use of Real World Data may address safety at a population level and help improve signal evaluation, as well as serve as reference to safety information during the lifecycle of a drug. Lastly, Dr Arellano mentioned advanced technologies like machine learning, automation and advanced analytics: these together can help automate the monitoring of large data sets potentially containing safety-relevant information and adverse events. Advanced analytics may help to predict safety outcomes and identify influencing factors, although more work is needed to refine these techniques.

Several presentations focused on Pharmacovigilance Outsourcing, a topic that is very close to our hearts. It’s now common for companies to outsource part or all of their pharmacovigilance activities, but this comes with pros and cons and presents some particular challenges. Bert Van Leeuwen, on behalf of the Product Safety Culture Initiative at ACRES (Alliance for Clinical Research Excellence and Safety), and Keya Pitts, from Astellas Pharma, addressed the topic in their presentations. The first focused on Principles and Guidance in PV Outsourcing, highlighting how important it is to evaluate the internal PV system and review all activities and SOPs critically before looking for a vendor. Vendors on their end need to be prepared to respond to Requests for Information/Proposals in a detailed manner. MAHs need to keep in mind that they are ultimately accountable for all activities, so vendors need to be selected carefully and the outsourced activities need to be agreed upon in detail with full oversight. The talk finally proposed the creation of PV Outsourcing standards, as to harmonise the requirements surrounding outsourced drug safety activities. Keya Pitts addressed the Quality Assurance aspects in outsourcing and set out a series of rules and best-practice advice to follow when considering outsourcing part of or all activities.

Adis Pharmacovigilance contributed with a talk on Local Literature Monitoring: balancing the benefits and burdens. The presentation was unique and very well received by our audience. Local literature monitoring (meaning the monitoring of non-indexed, local-language journals) is required by the current pharmacovigilance regulations, in order to identify case reports of adverse drug reactions: however, these regulations do not set out clear rules on how to do this. As a consequence, we see a number of different approaches in the industry, each with pros and cons. Setting up and then managing a local literature monitoring system comes with a number of challenges, which are discussed in the presentation. As a service provider, we act as a global vendor that offers a consistent and scalable approach, while ensuring high quality standards.

From our part, we will continue sharing our experiences, at conferences like this and in other settings. We believe that sharing current approaches across the industry is important when it comes to fostering the development of best practices,  so that we together with our customers and peers can find new and even better ways of ensuring patient safety.




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