Innovative Idea Generating Centre
09:00 Pharmacovigilance: Current Trends, Emerging Challenges, and Opportunities for Advancing Drug Safety and Regulatory
Practices.
This presentation delves into the latest trends in pharmacovigilance, including advancements in artificial intelligence, real-world evidence, and global harmonization of safety regulations. Key challenges such as data management complexities, adverse event reporting limitations, and evolving regulatory landscapes will be discussed. Additionally, the session will highlight emerging opportunities to enhance drug safety through proactive risk management strategies, improved stakeholder collaboration, and innovative technological solutions.
Gurpreet Singh Vice President, Managing Director Integrated Safety IQVIA
09:25 Questions & Discussion
09:30 Leveraging Quality Management Systems to Improve Pharmacovigilance Processes: A Comprehensive Approach to Ensuring Drug Safety and Compliance
Lizanne Pistorius Head of Patient Safety & Pharmacovigilance Boehringer Ingelheim
09:55 Questions & Discussion
A New Era of Drug Safety Panel Discussion:
10:00 Strengthening Pharmacovigilance for Effective Drug Safety Monitoring: Tackling Underreporting and Promoting Collaborative Solutions.
- Best Practices in Global Drug Safety – Showcasing innovative strategies to enhance risk management and patient-centric pharmacovigilance approaches. Galyna Cordero QPPV Head of Pharmacovigilance Department Farmak
- Real-World Data Utilization – Examining the impact of real-world evidence and patient-generated data in detecting adverse drug reactions.
- Collaborative Networks & Data Sharing – Highlighting the importance of cross-sector partnerships in strengthening global drug safety. Valentina Mancini Senior Director, Pharmacovigilance & QPPV Shionogi Europe
- Regulatory Advancements – Understanding the evolving regulatory landscape and its role in enhancing pharmacovigilance practices.
- Real-Time Monitoring for Rapid Response – Exploring technologies that enable proactive risk management and real-time adverse event tracking.
- AI-Driven Signal Detection – Discussing how artificial intelligence improves the speed and accuracy of adverse event detection. Dimitris Zampatis Director Product Patient Safety-TA Oncology and Immunology Sandoz
11:00 Interactive Discussion
11:30 Refreshment Break
12:00 Use of AI in Automation of Signal Detection tool
- Introduction and description of a new probabilistic method for causality assessment
- Automation of the tool by means of Large Language Models and predefined datasheets
- Comparing the outcomes of automated (AI driven) vs manual (human) assessment
- Exploring future use of the tool for conducting an automated semi-quantitative signals detection
Sanket Mahajan Safety Scientist, Pharmacovigilance Shionogi Europe
12:25 Questions & Discussion
12:30 The Future of Pharmacovigilance: From Reactive to Proactive Safety Systems
This discussion provides insights into the evolution of pharmacovigilance from traditional reactive approaches to advanced proactive safety systems. It will highlight the role of emerging technologies, real-world data, and predictive analytics in identifying and mitigating drug safety risks before they escalate. Attendees will gain insights into how regulatory frameworks, artificial intelligence, and global collaboration are shaping the next generation of patient safety monitoring.
Geeta N. Shanbhag Vice President Pharmacovigilance & Medico-regulatory affairs Ipca Laboratories Ltd.
12:55 Questions & Discussion
13:00 Lunch Break
Panel Discussion on Risk Management Plans:
14:00 Strengthening Safety Measures from Drug Development to Regulatory Approval for Optimal Patient Protection
- Global Pharmacovigilance Regulations - Ensuring Compliance and Safety through International Standards and Requirements.
Erika Barbarosie Associate Director Compliance R&D Quality
- Ensuring Regulatory Success – Optimizing Pharmacovigilance Approaches to Meet Market Authorization Standards and Ensure Comprehensive Drug Safety.
- Collaboration and Reporting – Uncovering Effective Stakeholder Communication Strategies for Ensuring Transparency and Promoting Drug Safety Initiatives.
- Advanced Detection of Adverse Drug Reactions (ADRs) – Examining Cutting-Edge Strategies for Detecting and Mitigating Adverse Drug Reactions.
- Effective Risk Mitigation in Clinical Trials - Delving into Strategies for Proactively Addressing Drug-Related Safety Challenges.
- Protecting Patient Safety - Analyzing Strategies for Monitoring and Ensuring Safety from Early Trials to Approval.
Akhilesh Chamediya Global Medical Director Patient Safety Alexion Pharmaceuticals, Inc.
15:00 Interactive Discussion
15:30 Refreshment Break
15:00 Enhancing Drug Safety through Patient Simplicity: Communication Approaches for Informed Benefit-Risk Decision
This session will explore the critical role of clear and effective communication in empowering patients to make informed decisions about their treatment options. By simplifying complex medical information, healthcare professionals can improve patient understanding of drug safety, benefit-risk profiles, and potential adverse effects. The talk will focus on strategies for presenting information in an accessible, patient-friendly format, using visuals, plain language, and tailored messaging. We will discuss how these approaches can enhance patient engagement, promote shared decision-making, and ultimately improve patient outcomes. Attendees will learn best practices for communicating the benefit-risk balance of medications, ensuring patients are well-informed and able to actively participate in their healthcare decisions.
Michael Von Forstner Head of Global Safety Science Sobi - Swedish Orphan Biovitrum AB (publ)
15:25 Questions & Discussion
15:30 Refreshment Break
16:30 Patient-Centered Pharmacovigilance: Bridging the Gap Between Reporting and Real-World Evidence
This talk explores the evolving role of patients in pharmacovigilance, emphasizing the importance of real-world data in enhancing drug safety. By integrating patient-reported outcomes with traditional reporting systems, we can bridge the gap between adverse event reporting and actionable real-world evidence. The session will highlight innovative strategies, emerging technologies, and collaborative approaches to make pharmacovigilance more patient-centered and impactful.
David Gillen Chief Medical Officer Norgine
16:55 Questions & Discussion
17:00 AI Will Revolutionize PV As We Know It Today But Does Anyone Know How To Validate It?
- Regulatory requirements for using AI in pharmacovigilance
- Principles of how large language models work
- Planning, executing and documenting AI validation
Giovanni Furlan Senior pharmacovigilance professional
17:25 Questions & Discussion
17:30 End of conference
REVOLUTIONIZING PHARMACOVIGILANCE AND RISK MANAGEMENT
Discover how emerging technologies, data-driven strategies, and regulatory advancements are reshaping adverse event detection and patient safety worldwide.
25 JUNE 2025 | VIRTUAL CONGRESS(BST)
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