Reshaping Global ICSR Reporting to Deliver Real-Time Visibility and Oversight

Directly supporting multilingual case processing and regional regulatory requirements in a global pharmacovigilance solution, eliminates multiple reporting systems and provides a single trusted source of safety information. With real-time and unified data foundation, it is easier to track compliance and enable more timely reporting, submissions and distribution. In this webinar, the featured speaker will focus on managing ICSR reporting with improved pharmacovigilance solutions.

The traditional “hub and spoke” model for affiliate safety data management and reporting is inefficient with siloed information and lack of data standardization. Often, there are affiliate-specific workflows and multilingual intake and submission. Maintaining oversight and quality is challenging with a fragmented view, and impacts analysis and downstream requirements such as aggregate reporting.

Pharmacovigilance teams need agile processes for collecting and reporting data that can easily scale with increasing number of adverse events and evolving regulatory landscape. Allowing affiliates to process local cases in a global safety solution centralizes information and delivers greater oversight and monitoring for pharma companies.

Modern solutions are transforming safety with collaborative and streamlined processes by providing a flexible security model, greater accessibility to pharmacovigilance data and highly configurable workflows. Companies can manage the entire ICSR reporting lifecycle — with full visibility and traceability from collection to case submission, even when outsourcing and working with affiliates.

With real-time safety data, pharmacovigilance teams can improve compliance and perform timely benefit-risk evaluation and decision-making. Register to learn about reshaping global ICSR reporting to deliver real-time visibility and oversight.

Speaker

David Kolosic, Senior Manager, Safety Strategy, Veeva Systems

David is a Senior Manager for Vault Safety Strategy at Veeva and has almost a decade of experience in multiple disciplines, including pharmacovigilance, quality management, regulatory information management and business development. He has helped pharma companies transform departments to become more efficient, collaborative and ultimately successful with modern technologies. David holds a Bachelor of Science (BSc), Pharmaceutical Studies (Hons) and a Master of Science (MSc), Pharmaceutical Science and Management Studies from Kingston University, London, UK.

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