Pharmacovigilance

Pharmacovigilance is being transformed by claims and EHR-based real-world evidence, NLP-driven signal detection on social media and call-center transcripts, and the FDA Sentinel system's expanding role in active surveillance. WCPD 2027 will cover post-marketing experience with novel modalities — gene therapy long-term follow-up registries, GLP-1 agonist gastrointestinal and ocular signals, and the safety profile of compounded GLP-1s entering the market during shortages. Sessions will also address pregnancy registries, REMS modernization, machine learning for ICSR triage, and the global divergence in ADR reporting standards across FDA FAERS, EMA EudraVigilance, and WHO VigiBase.