Apellis Pharmaceuticals shares their experience on quickly moving to a comprehensive and validated cloud safety solution. With one system for case intake, case processing, reporting, submissions, and all document management activities, such as pharmacovigilance safety master file (PSMF) and pharmacovigilance (PV) agreements, pharmacovigilance processes are consolidated, simplified, and streamlined. The safety team can perform many different activities without having to switch between multiple applications: search for duplicates, view any case version, create user-specific line listings and visualizations, seamlessly drill down into the case narrative, see previous edits, revisions and annotations, electronically submit ICSRs and exchange case reports with business partners, and create aggregate report data and written content based on company-specific templates.
Cloud also enables all parties to easily engage on the same platform, promoting greater oversight and alignment. Apellis can provide specific access to partners or internal teams access, supporting collaboration while controlling what users see or do in the application.
Learn how Apellis evaluated a pharmacovigilance system and why they chose a modern solution including:
Who Will Benefit
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VP, Safety and Pharmacovigilance, Apellis Pharmaceuticals
Marc is responsible for the safety risk management of Apellis products, supporting safe and informed treatment, and fulfilling global regulatory requirements for patient safety. With 18 years in safety risk management, he has extensive experience in safety surveillance and risk mitigation with marketed products and drugs in development at companies such as Roche, GlaxoSmithKline, and BeiGene. Dr. Morris has a special interest in specialty therapies for patients with serious illnesses, including pharmaceuticals and biological products. Dr. Morris has degrees in biochemistry and medicine from the University of London, a masters in pharmaceutical medicine from the University of Surrey, and a law degree from Temple University.
VP, Safety Strategy and Consulting, Veeva Systems
Kelly is a leader at Veeva with over 18 years of industry and consulting experience supporting Biotech and pharmaceutical companies. She has extensive knowledge and experience with the US FDA, and EMA Safety and Quality regulations. Kelly has applied specialized knowledge of regulatory and compliance aspects of business processes across life sciences to define and implement strategy, design/re-design processes, support technology implementations, and define governance across the spectrum of PV activities. She brings in-depth industry knowledge and awareness to help clients define their goals and objectives to stay aligned with industry-leading practices and remain competitive in the marketplace.