What Will Be Covered:
- Limitations of conventional signal detection in fixed-dose combinations and drug–device products.
- Integrating quantitative screening with clinical, temporal, mechanistic, and exposure-based evidence to strengthen signal assessment.
- Distinguishing component-related, interaction-driven, and delivery-system risks from other contributing factors.
- Translating validated signals into effective risk management, including monitoring, communication, and risk minimisation strategies.
About The Webinar
Combination products, including fixed-dose drug combinations and drug–device configurations, present unique challenges for pharmacovigilance. Safety outcomes may arise from individual components, interactions, delivery systems, or the clinical context in which products are used.
Conventional signal detection methods, including disproportionality analyses, can struggle with statistical noise, signal masking, polypharmacy, overlapping toxicities, and complex drug interactions, making clinically meaningful signals harder to identify and assess.
This webinar explores a practical, risk-based approach to detecting, validating, and prioritising safety signals in combination products. Through representative scenarios, it will demonstrate how quantitative screening can be strengthened by clinical assessment, temporal analysis, interaction plausibility, and real-world evidence to support more informed signal evaluation and proportionate risk management.
About the Speaker:
Dr. Prachi Arora heads Medical Safety at APCER, leading aggregate reporting, risk management, and signal management. With over 20 years of clinical, academic, and industry experience, including 17+ years in pharmacovigilance, she brings deep expertise in safety science and medical oversight.
