10th Global Pharmacovigilance & RWE FORUM
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
key information
- Location: Hilton London Olympia, 380 Kensington High Street, London W14 8NL, United Kingdom
- Part of the Pharmacovigilance World Tour
- April 9-10, 2025
- 9:00 - 17:30 Local Time
About the event
Welcome to the 10th Pharmacovigilance & RWE Forum, a culminating conference of our World tour of Pharmacovigilance in heart of European pharma industry, London! After our last annual event we are thrilled to gather our vibrant community of safety professionals to explore the future of pharmacovigilance.
Our event features inspiring keynotes, practical case studies, and engaging panel discussions, offering insights from passionate industry experts. Join our numerous networking opportunities to build crucial business relationships and keep up to date with industry developments.
Let’s come together in London to advance our mission of delivering safer, faster, and more sustainable medicines to patients.
OUR FLAGSHIP EUROPEAN PV EVENT, HERE’S WHAT YOU CAN EXPECT:
- PEER-TO-PEER NETWORKING: We specialize in providing peer-2-peer level networking experience for pharma & biotech professionals.
- TOP-MANAGEMENT EXPERTISE: Bringing together the industry leaders in the field to share strategic perspectives and insights that are shaping the industry.
- IN-DEPTH & INTERACTIVE: In contrast to loud, large-scale exhibitions, our events are setup to be discussion-driven for our participants to have meaningful conversations in a relaxed networking environment.
KEY TOPICS
- 2025 outlook, trends and upcoming challenges
- RWE and regulatory decision-making updates
- Challenges for individualized patient outcomes and targeted therapies
- Implementing real-time RWE surveillance with legacy systems
- Ensuring data integrity and accuracy in safety reporting
- Strategies for RWE into existing PV frameworks
- Detecting subtle safety signals
- Automation for heightened efficiency, precision, and compliance in risk management
- Global regulatory and compliance harmonization
Target audience
- Drug safety & Pharmacovigilance executives
- Heads of global safety programs
- QPPVs
- Benefit-Risk assessment management
- Medical affairs management
- RWE specialists
- Patient safety management
- Compliance specialists
- Post-market researchers
- PV auditors
- Regulatory affairs directors
- EMA professionals
- Compliance specialists
- Pharma IT management
- Safety consultants
Event Speakers
Dr Adrian Rabe
Head of the RWE CoE
Boehringer Ingelheim & Visiting Professor, Primary Care and Public Health, Imperial College London
Fabio De Gregorio
Vice President & Head of Drug Safety
Shionogi Europe
Sanket Mahajan
Safety Scientist, Pharmacovigilance
Shionogi Europe
Rishi Chopra
Executive Director, Head of International Pharmacovigilance (IPV) & Global PV Operations
CSL Behring
Michael von Forstner
Head Of Safety Science
Sobi
Tasi (Anastasia) Lampropoulou
Director, Global Integrated Evidence Planning
Novartis
Vijay Kara
Safety and Quantitative Innovation Director
GSK
Amer Alghabban
R&D Quality Regulatory Authority Inspection Management
Bristol Myers Squibb
Muhammad Memon
Chief Medical Officer
Complement Therapeutics
Andrea De Iacovo
Global Head of Pharmacovigilance
Besins Healthcare
event partners
Pharmora was established in 2010 and remains a family managed business, offering the highest standards of delivery and customer care. We have grown to become an international business, with operations in the UK and the EU, providing global medical review services for the clinical development and safety surveillance of medical products. Pharmora has extensive safety expertise and has supported clients in managing reviews and documentation across the whole spectrum of safety data. We provide support from the first clinical trials to ongoing commercialisation and have a highly capable team of medics and scientists available to provide flexible and dedicated assured services, at your convenience.
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.
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.
Founded in 2008, NostraPharma is a premier boutique consultancy with ISO 9001:2015 certification, specializing in pharmacovigilance (PV), quality and training. With over 900 years of combined expertise, we provide tailored, high-quality solutions designed to support our clients throughout the quality and PV lifecycle. Our commitment to quality ensures a personalized service, helping businesses navigate regulatory requirements with confidence and efficiency.
At NostraPharma, we provide dedicated, tailored support that ensures regulatory compliance to enable patient safety. Our experts have conducted over 200 audits on average and have extensive knowledge of health authority inspections including those by the FDA, EMA, HPRA, MHRA, Health Canada, as well as regulatory authorities in France, Spain, Croatia, Turkey and Hungary. We excel in managing complex inspection responses, challenging resources and products or database situations, helping our clients navigate regulatory challenges with confidence and efficiency.
Core service areas:
- Strategic PV/Quality Consultancy
- AI/Algorithm & GxP Auditing
- PV and Quality Training
- QPPV support
- PSMF
- PV system set up/improvements
At Alwis Group, we’re pioneering AI-driven solutions for the healthcare and pharmaceutical industries. Our innovative tools are transforming pharmacovigilance, enhancing drug safety monitoring, and streamlining regulatory compliance. Our suite of products includes:
- ReTrans Enterprise: AI-powered literature surveillance
- ReTrans Extension: Browser plugin for real-time safety data analysis
- ScoMed: Intelligent medical literature scoring * ZiNex: Advanced medical document processing
- ZiQuel: AI-driven quality complaint management
- ZiTrack: Smart inbound receipt management
We’re committed to improving patient safety and operational efficiency through cutting-edge technology. Our solutions reduce costs, minimize errors, and accelerate processes, allowing healthcare professionals to focus on what matters most – patient care.
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REGISTRATION
Conference
Ticket | April 9-10, 2025-
Access to All Conference Sessions of the 10th Global Pharmacovigilance & RWE Forum
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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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