Takeaways from ICPE

Takeaways from ICPE

UBC’s distinguished scientists recently participated in the 32nd International Conference on Pharmacoepidemiology & Therapeutic Risk Management in Dublin. The team presented abstracts and attended a variety of sessions. Here were three key takeaways relating to the blossoming need for real-world evidence.

  1. No PASSing Zone
    EU regulator requests for Post-Authorization Safety Studies (PASS) are on the rise. These studies explore the benefit-risk profile of marketed products. Our free whitepaper covers the essential building blocks of a PASS and helps sponsors secure rapid regulatory approval. 
     
  2. Big Data on the Big Stage
    FDA’s Sentinel program using “big data” in a distributed data network is ready for prime time. Pharma and biotech manufacturers will increasingly see and have to respond to FDA-backed active safety surveillance evidence from these data. The data from this distributed data network are also directly accessible by industry professionals on a limited basis.
     
  3. Safety First
    Now more than ever, product sponsors need to be proactive when it comes to understanding the safety profiles of their products. UBC’s proprietary software SAEfetyWorks® and CLÆRITY® effectively and systematically utilizes real-world healthcare data to provide rapid, reliable insight into the safety and utilization of marketed medications along with trends in healthcare.

With all this momentum behind the need for additional real-world data, UBC can help product sponsors generate targeted, real-world evidence to deliver compelling value messages. Contact us or click here to learn more.