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

Life Sciences, Pharmaceutical Regulation, Pharmacovigilance,
  • Tuesday, October 25, 2022

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

http://David%20Kolosic,%20Veeva%20Systems

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.

Message Presenter

Who Should Attend?

This webinar will benefit those involved in pharmacovigilance, with relevant areas of expertise and job titles, including:

  • Biosafety Professionals
  • Safety Managers
  • Risk Managers
  • Regulatory Specialists
  • Heads of Pharmacovigilance (PV)
  • Heads of Pharmacovigilance (PV) IT
  • Heads of Safety Operations
  • Safety Specialists
  • EU QPPV
  • Safety Scientists
  • Aggregate Report Specialists
  • PV Agreements Specialists
  • PSMF Coordinators
  • Medical Reviewers

What You Will Learn

Attendees will gain insights into:

  • Challenges and approaches to safety data management and ICSR reporting
  • How technology makes it easier to comply with global and regional requirements
  • Considerations for incorporating affiliates into one pharmacovigilance solution
  • Strategies for adopting a single multilingual safety solution to meet country specific regulatory requirements

Xtalks Partner

Veeva

Veeva is the global leader in cloud software for the life sciences industry. Committed to innovation, product excellence, and customer success, Veeva serves more than 1,100 customers, ranging from the world’s largest pharmaceutical companies to emerging biotechs. As a Public Benefit Corporation, Veeva is committed to balancing the interests of all stakeholders, including customers, employees, shareholders, and the industries it serves. For more information, visit www.veeva.com/eu.

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