Track 07 of 9
Pharmacovigilance
Real-world evidence, signal detection, patient registries.
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.
Focus areas
- FDA Sentinel and active surveillance for novel modalities
- GLP-1 receptor agonist safety: GI, ocular, suicidality signals
- Compounded GLP-1 quality and adverse event reporting
- Gene therapy long-term registries and delayed toxicities
- NLP and ML for ICSR triage and social-media signal detection
- REMS modernization and risk minimization measurement
- Pregnancy and lactation registries; teratovigilance