Panel Discussion on Risk Management Plans: 

14:00 Strengthening Safety Measures from Drug Development to Regulatory Approval for Optimal Patient Protection

• 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.
• Global Pharmacovigilance Regulations - Ensuring Compliance and Safety through International Standards and Requirements.
• 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.

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

16:00 Harnessing Big Data for Effective Pharmacovigilance and Risk Management.

This talk explores how big data analytics is transforming pharmacovigilance and risk management in the pharmaceutical industry. It will cover innovative data-driven approaches to detecting adverse drug reactions, improving patient safety, and ensuring regulatory compliance. Attendees will gain insights into leveraging real-world data, artificial intelligence, and machine learning to enhance drug safety monitoring and decision-making.

16:25 Questions & Discussion

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 Pharmacovigilance in the Post-Market Phase: Monitoring Long-Term Drug Safety

This session explores the critical role of pharmacovigilance in the post-market phase, focusing on the continuous monitoring of drug safety beyond clinical trials. Attendees will gain insights into adverse event reporting, real-world data analysis, and regulatory requirements to ensure long-term patient safety and effective risk management.

17:55 Questions & Discussion

18:00 Pharmacovigilance in the Era of Personalized Medicine: Challenges and Opportunities

This session investigates how tailored treatments impact drug safety monitoring, the role of real-world data and AI in adverse event detection, and strategies to enhance regulatory frameworks. Attendees will gain insights into adapting pharmacovigilance practices to ensure patient safety in an era of precision therapeutics.
 

18:25 Questions & Discussion

18:30 End of conference