Dr. Manal Younus is a pharmacovigilance and regulatory systems expert and Director of the Iraqi Pharmacovigilance Center at the Ministry of Health, Iraq. She is actively engaged in global pharmacovigilance, regulatory systems strengthening, and patient safety and, as a WHO Global Benchmarking Tool assessor, has contributed to evaluations of national regulatory authorities in several countries.

She is a member of the WHO Technical Advisory Group on Regulatory Systems Strengthening (WHO TAG-RSS), a Fellow of the International Society of Pharmacovigilance (ISoP), and a Patient Safety Fellow of the Patient Safety Movement Foundation(PSMF). She serves on the CIOMS Executive Committee and contributed, and contributed to CIOMS Working Group XI on patient involvement in the development, regulation and safe use of medicines. She also served two consecutive terms on the ISoP Advisory Board from 2019 to 2025.

Her professional interests include strengthening pharmacovigilance and regulatory systems, patient engagement, risk minimisation, and integrating safety science into healthcare education and practice. She has authored or co-authored more than 50 scientific publications and serves on the Editorial Board of Drug Safety.

From Reaction to Readiness: Rethinking Pharmacovigilance and Regulatory Systems for the Next Pandemic

The COVID-19 pandemic placed unprecedented demands on pharmacovigilance and regulatory systems, revelling both their resilience and their vulnerabilities. Rapid vaccine development and deployment required equally rapid approaches to safety monitoring, signal detection, regulatory decision-making, risk communication, and public engagement. These experiences provide important lessons for strengthening preparedness for future public health emergencies.

Drawing on the key themes of the Research Topic Pandemic Preparedness in Vaccine Safety and Regulation, this presentation examines how pharmacovigilance and regulatory systems can move from reactive crisis management toward continuous readiness. Priorities include scalable safety surveillance infrastructure, timely access to high-quality data, stronger linkage between vaccination, adverse event, and healthcare databases, harmonized approaches to signal assessment, and  adaptable medical terminology and coding systems that can respond to emerging safety concerns.

Preparedness also requires regulatory systems capable of accelerating evidence generation and decision-making without compromising scientific rigor, ethical standards, or transparency. Effective risk communication and public trust are equally important, as confidence in regulatory and safety systems directly influences acceptance of public health interventions.

The presentation will also consider the broader implications of initiatives such as the 100 Days Mission, emphasizing that surveillance systems, research networks, regulatory capabilities, data infrastructure, and trained human resources must be maintained between emergencies rather than assembled only after a crisis begins.

The central message is that pandemic preparedness should be viewed as a standing capability: continuously maintained, interconnected, adaptable, and able to scale rapidly when required. Building these systems before the next emergency will be essential for faster safety assessment and regulatory action while preserving scientific integrity, ethical oversight, and public trust.