February 25-26 / Barcelona, Spain
European Drug Safety & PV Outsourcing Summit Barcelona
BARCELONA | 2025
World’s greatest minds in drug safety, pharmacovigilance, data analysis, reporting, government policy, and innovative technology united under the Why Summits Future of Pharmacovigilance World Tour
What to expect
Welcome to the World Drug Safety Summit, a culminating conference of our World tour of Pharmacovigilance in heart of European pharma industry, beautiful Barcelona! After last annual event we are thrilled to gather our vibrant community of safety professionals to explore the future of pharmacovigilance. In this conference we will focus on the true meaning of patient centricity in pharmacovigilance including real-world use cases along with game-changing impact of Artificial intelligence in PV, we will discuss possibilities of low-end digital disruption, strategic roles in PV, risk management, automation, leadership, and clinical safety. Learn how to integrate disruptive technologies, manage budgets, and build effective teams.
Our event features inspiring keynotes, practical case studies, and engaging panel discussions, offering insights from passionate industry experts. Plus, enjoy numerous networking opportunities to build crucial business relationships.
Let’s come together in Barcelona to advance our mission of delivering safer, faster, and more sustainable medicines to patients.
Team Why Summits
Main takeaways
- Pan-European PV updates: 2025 outlook, trends and upcoming challenges
- Expanding pipeline & increased demand for PV outsourcing
- Evolving EU regulations & required strategies to adapt
- Aligning outsourcing strategy with the overall safety function strategy
- Ensuring data integrity and accuracy in safety reporting
- Advancements in Benefit-Risk assessment and aRMMs
- Optimizing PV outsourcing for post-market safety data
- Inspection Readiness Through Effective Third Party Management & Oversight
- Patient-centric approaches in signal detection
- Key considerations for aligning external PV services with internal workflows
Everything you need to know about this event in one spot.
Check out our event overview and agenda and discover European Drug Safety & PV Outsourcing Summit Barcelona.
Event Speakers
Gurpreet Singh
Vice President, Managing Director Integrated Safety
IQVIA
Annette Humes
Global Head of Safety Resource & Alliance Management and Chief of Staff (Safety)
Roche
Offiong Ani
Associate Director, Third Party Strategy & Oversight, Worldwide Patient Safety
Bristol Myers Squibb
Mark Cawley
Associate Director, Research Procurement (Reg Affairs, PV & Med Affairs)
Jazz Pharmaceuticals
Franziska Rathjens
Director Global Pharmacovigilance & Patient Safety, Deputy QPPV
B Braun Gruppe
Ivanna Mikhailovna Rosendal
Vice President of Business Digitalization
Ascendis Pharma
Roger Mutter
Medical Safety Director
Alfasigma
Darko Krnic
Head of Pharmacovigilance
Pharma&
Mabel Abad Ramos
Patient Access Lead for Access to Medicines, Growth & Emerging Markets (GEM)
Stefanie Amend-Mall
Director Patient Safety HUB Europe
Sandoz
Past Event Partners
Industry Pioneers Attending From
Testimonials
REGISTRATION
Conference
Ticket | February 25-26, 2025-
Access to All Conference Sessions of the European Drug Safety & PV Outsourcing Summit Barcelona
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Access to Post Conference Networking
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Conference Materials
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Includes Coffee Breaks, Snacks and Refreshments, Seated Lunch
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Event partners
Silver Partner
Quark empowers the world’s largest pharmaceutical companies to automate the production of their highly regulated or complex documentation, so they can approve and publish it faster, and stay compliant. It enables them to accelerate regulatory approvals, release the bottlenecks around content collaboration, and get their drugs to market in record time.
Quark Publishing Platform (QPP) NextGen, the cloud-based, AI-powered component content management system (CCMS) with native XML-based structured authoring using Microsoft Word, helps pharmacovigilance teams centralize and simplify the processes involved in co-authoring and approving the PV system’s critical drug safety documentation. This starts with the master file (PSMF) and traverses through all aggregated and regulatory affairs reports, including development safety update reports (DSURs), periodic adverse drug experience reports (PADERs), periodic safety update reports (PSURs), periodic benefit-risk evaluation reports (PBRERs) and risk management plans (RMPs).
Powered by Microsoft Azure OpenAI and connected with wider content and business software ecosystems such as Veeva and ArisGlobal, QPP NextGen manages every stage of the authoring and review lifecycle from end to end. PV teams increase productivity and save time by easily writing, importing, formatting and publishing complex types of variable global content to omnichannel submission outputs using structured, XML component-based authoring workflows, stringently tracking workflows in real time, driving risk reduction and safeguarding compliance.
Silver Partner
Accelerating Patient Safety: Leading with Evidence, AI and Scientific Expertise.
Biologit MLM-AI is a state-of-the-art platform for monitoring scientific literature to identify adverse events and emerging risks throughout a product’s lifecycle, from clinical development to post-marketing. Designed for teams of all sizes, it combines a flexible workflow with a unified global and local scientific database, enhanced by unique AI-driven screening and productivity tools. These features enable fast, accurate, and fully traceable results for all safety surveillance needs.
Biologit Database is a robust, continuously updated repository of scientific literature, optimised for compliant regulatory searches. It integrates global and regional sources into an intuitive interface, delivering high-quality results for monitoring adverse events and potential risks. With over 65 million entries and 40,000 new articles added daily from 120,000 journals across 170+ countries, it ensures comprehensive coverage aligned with FDA, EMA GVP and global standards.