Optimizing Pharmacovigilance And Risk Management Strategies To An Evolving Drug Safety Environment
As medical science advances, so does our understanding of drug safety and the need for vigilance when it comes to monitoring its usage. In recent years, pharmacovigilance has gained significant attention and importance due to the growing complexity of drug therapies, the emergence of new medicines, and the increased scrutiny of regulatory agencies. This has led to a greater emphasis on monitoring the safety profiles of pharmaceutical products throughout their lifecycle, from pre-marketing clinical trials to post-marketing surveillance.
The need for effective pharmacovigilance systems becomes even more crucial as the global population continues to expand, resulting in an increased consumption of medications. Adverse drug reactions (ADRs) can have severe consequences, leading to hospitalizations, prolonged treatments, and in some cases, even fatalities. Therefore, it is imperative to enhance our understanding of ADRs, identify potential risks, and implement appropriate risk mitigation strategies. To efficiently address these challenges, collaboration between international regulatory bodies, healthcare providers, and patients is essential. With a strong focus on patient safety as well as public health and by creating an interconnected network of experts from around the world who are dedicated to advancing our understanding of drug safety and pharmacovigilance, we can create a robust system.
This conference will serve as a knowledge-sharing and networking platform, providing a unique opportunity for researchers, pharmacists, healthcare professionals, industry representatives, and regulatory authorities to come together and discuss the latest trends, challenges, and advancements in pharmacovigilance. By sharing experiences and best practices, we aim to enhance global drug safety and improve patient outcomes. Throughout the conference, we will delve into various topics such as signal detection and management, adverse event reporting and analysis, risk assessment, benefit-risk evaluation, regulatory updates, collaboration and the integration of artificial intelligence and digital technologies in pharmacovigilance.
Our esteemed panel of speakers, comprising leading experts from academia, industry, and regulatory agencies, will present their research findings, share case studies, and engage in thought-provoking discussions. The conference will also feature interactive networking opportunities, fostering collaboration and enabling the exchange of ideas.
We are delighted to welcome you to the Pharmacovigilance World 2025, and we are confident that your active participation will contribute to the advancement of drug safety practices. Together, let us strive towards a safer and more vigilant healthcare system that prioritizes patient well-being and ensures the continued benefit of medications worldwide.
Conference Streams Include
- Global PV & Methodologies
- Data Management & Analytics in PV
- PV Automation, AI & Machine Learning
- Safety Signals & Management
- Pharmacovigilance Regulations
- Risk Management
- Patient-Centric Drug Safety
- Case Management
- Quality & Compliance
- Pharmacovigilance Outsourcing
- Medical Devices Safety
- Adverse Drug Reactions
Key Discussions We'll Be Exploring
- Pharmacovigilance and globalization
- Pharmacovigilance in a pandemic world
- Women and child healthcare medicines and pharmacovigilance
- Patient-centric approaches in PV
- Pharmacovigilance legislation and regulations
- Harmonization and pharmacovigilance
- Advanced therapeutic techniques and pharmacovigilance
- Pharmacovigilance and data management and eudravigilance
- Post-marketing surveillance in pharmacovigilance
- PV regulations and challenges
- Benefit-risk management strategies
- Risk management and minimization
- Risk Evaluation and Mitigation
- Adverse drug reaction reporting
- Signal detection and post-authorization safety
- Good Pharmacovigilance Practices
- Innovative approaches to drug safety
- Strategies to improve PV
- Real-World Evidence in PV
- Big data and AI in pharmacovigilance
- Pharmacovigilance Workflows with AI & Automation
- Other emerging technologies in PV
Agenda
08:00 AM - 08:50 AM - 50 Minutes
Registration & Refreshments
Kick off your conference experience by checking in at our registration desk. Collect your event materials and enjoy a selection of refreshments. It's the perfect time to mingle with fellow attendees and set the tone for an engaging and informative event
08:50 AM - 09:00 AM - 10 Minutes
Chairperson’s Opening Remarks
Begin your conference journey with a warm welcome from our esteemed Chairperson
09:00 AM - 09:30 AM - 30 Minutes
Elevating Pharmacovigilance Systems: Achieving Excellence in Audit and Inspection Readiness
- How detailed understanding of consumer behavior and sales information can bolster pharmacovigilance effectiveness and audit preparedness.
- Initiatives to raise awareness about generic medications and strategies to minimize medication errors in private clinics.
- The impact of industrial associations in enhancing compliance and setting higher standards in pharmacovigilance practices.
Carolina Narvaez Rodriguez
Head Patient Safety Region Europe Novartis
Novartis
09:30 AM - 10:00 AM - 30 Minutes
Reimagining Patient Safety: Driving Scalable, Patient-Centric Innovation Across Global PV Systems
Penelope Timpert-Argust
Senior Business Process Leader, Global Patient Safety & Risk Management
Roche
10:00 AM - 10:30 AM - 30 Minutes
Mastering Compliance and Best Practices in Drug Safety Monitoring
- Effective strategies for establishing and maintaining comprehensive adverse event reporting mechanisms, crucial for timely detection and response to drug safety issues.
- The challenges and strategies for staying compliant with the diverse and evolving pharmacovigilance regulations across different countries and regions.
- The importance of ongoing training, education, and process evaluation within organizations to ensure adherence to best practices in pharmacovigilance and continual enhancement of drug safety monitoring.
10:30 AM - 10:50 AM - 20 Minutes
Business Card Exchange with Morning Coffee/Tea & Discussion
Network over morning coffee or tea, exchanging business cards or using our app's QR code scanner for easy contact sharing. A prime moment for engaging discussions and new connections
10:50 AM - 11:20 AM - 30 Minutes
Designing Patient-centric Risk Management Strategies throughout the drug development cycle
Suzanne Foncin
Scientific Director, Safety Evaluation & Risk Management
GSK
11:20 AM - 11:50 AM - 30 Minutes
Case processing and adverse reaction reporting
Tobi Yusuf
Associate Director PV Processes and Partnerships
AstraZeneca
11:50 AM - 12:20 PM - 30 Minutes
Innovative Therapies and Vigilant Pharmacovigilance: Ensuring Safety in the Era of Medical Breakthroughs
- How pharmacovigilance practices are evolving to keep pace with the rapid development of innovative therapeutic techniques.
- The challenges and complexities in monitoring and ensuring the safety of patients undergoing advanced therapeutic treatments
- Conducting thorough benefit-risk assessments for Advanced Therapy Medicinal Products (ATMPs) to balance their ground-breaking potential against safety concerns.
12:20 PM - 12:50 PM - 30 Minutes
Panel Discussion - Global Pharmacovigilance Today: Setting the Stage for Excellence in Drug Safety
- Understanding the global pharmacovigilance ecosystem: Key players and their roles.
- Challenges in achieving global regulatory harmonization and compliance
- The impact of real-world evidence and big data on modern pharmacovigilance practices.
- Collaboration as a cornerstone for ensuring patient safety across borders.
Purity Wanjiku
Qualified Person for Pharmacovigilance
Eli Lilly and Company
Raghda Mohamed
Patient Safety Cluster Lead - Middle East and Turkey / Global patient Safety Evaluation
Takeda
12:50 PM - 13:30 PM - 40 Minutes
Luncheon & Networking - Visit Exhibitor Booths & Network with your peers in our Lounge
Enjoy a luncheon while networking with peers and exploring exhibitor booths. This is an ideal time to engage with industry leaders, delve into innovative solutions, and forge valuable connections in a collaborative atmosphere.
13:30 PM - 14:00 PM - 30 Minutes
Adapting to the Changing Environment Without Losing Our Core Purpose
Begum Benli Peker
Head of Patient Safety EU Hub
Bristol Myers Squibb
14:00 PM - 14:30 PM - 30 Minutes
Integrating Probabilistic Causal Inference into Signal Management
Fabio De Gregorio
Vice President, Head of Drug Safety Europe
Shionogi Europe
14:30 PM - 15:00 PM - 30 Minutes
Pharmacovigilance and Healthcare Data Privacy and Data Protection in the Healthcare Digital Age
Purity Wanjiku
Qualified Person for Pharmacovigilance
Eli Lilly and Company
15:00 PM - 15:30 PM - 30 Minutes
Hidden Signals, Smart Algorithms: How AI is Transforming Safety Detection
In today’s complex and data-saturated pharmacovigilance environment, traditional signal detection methods are no longer sufficient. This presentation will explore how AI and machine learning can support the identification of complex or hidden safety signals, improve signal prioritization, and enhance patient safety outcomes - while remaining compliant and audit-ready.I will emphasize that AI does not replace pharmacovigilance experts - it empowers them, enabling faster, more accurate decision-making and ultimately helping to protect patients more effectively.
- Limitations of traditional signal detection in the post-marketing setting
- How AI and machine learning models can support signal identification and triage
- Use of NLP to extract insights from unstructured narratives
- Benefits and risks of integrating AI in PV workflows
- Regulatory and inspection readiness: balancing innovation and compliance
- Key takeaways: what safety professionals need to know before implementing AI
Weronika Dardzinska
Scientific Manager/ Safety Lead/ Safety Evaluation and Risk Management Principal Scientist
GSK
15:30 PM - 15:50 PM - 20 Minutes
Grab your Tea/Coffee - Visit our Exhibitor Booths & Network with your colleagues
Refresh with a tea or coffee break, using this time to continue networking. It's a perfect opportunity to discuss ideas, share experiences, and connect with fellow attendees in a relaxed setting.
15:50 PM - 16:20 PM - 30 Minutes
Pharmacovigilance as a Financial Enabler: Unlocking Business Value Beyond Compliance
Dimitris Zampatis
Director Product Patient Safety-TA Oncology and Immunology
Sandoz
16:20 PM - 16:40 PM - 20 Minutes
Industry Frontiers in Pharmacovigilance: Advancing Post-Marketing Signal Detection and Management
- The strengths and weaknesses of existing drug safety signal detection systems and tools, setting the stage for innovation.
- Latest advancements and emerging technologies in the detection and management of safety signals, highlighting their potential to transform the industry.
- Exploring the variety of sources, including novel and underutilized ones, for identifying safety signals, emphasizing the importance of a comprehensive approach.
16:40 PM - 17:00 PM - 20 Minutes
AI & Machine Learning's Game-Changing Role in Pharmacovigilance and Drug Safety
Adriano Galati
Patient Safety Director, Behavioral Science & Design (PharmacoVigilance & Scientific Development)
Roche
17:00 PM - 17:20 PM - 20 Minutes
Enhancing Patient Safety Through Pharmacovigilance Auditing: Strategies, Challenges, and Compliance Best Practices
Smita Singh
Quality Compliance Manager
Amgen
17:20 PM - 17:50 PM - 30 Minutes
International harmonization and drug regulatory requirement in MENA region
- Sales, information and knowledge of consumers
- Awareness, generic names, reduction of medication errors in private clinics
- Industrial association
Mina Awad
Pharmacovigilance Senior Manager and QPPV, Middle East
Kyowa Kirin International plc
17:50 PM - 18:25 PM - 35 Minutes
Round Table Discussion:
All the participants will have a great opportunity to discuss and explore a selection of most interesting topics discussed during the conference in small groups with their industry colleagues in an informal setting. Each table will nominate a head who will summarise the discussion and questions posed. The group members are given equal rights to share and learn from each other's experiences to discover an actionable solution on the discussed topic.
18:25 PM - 18:35 PM - 10 Minutes
Chairperson’s Closing Remarks
18:30 PM - 19:30 PM - 60 Minutes
Networking Drinks Session - Unwind with Evening Drinks and Engaging Conversations
Wrap up the day with evening drinks and lively conversations. A relaxed setting to network, share insights from the day, and enjoy the company of fellow attendees.
Day 2
08:00 AM - 08:50 AM - 50 Minutes
Registration & Refreshments
Start the second day of the conference by checking in and grabbing a morning refreshment. It’s a great opportunity to re-engage with peers, discuss the previous day’s insights, and prepare for another day of learning and networking.
08:50 AM - 09:00 AM - 10 Minutes
Chairperson’s Opening Remarks
Start the second day with insightful remarks from our Chairperson
09:00 AM - 09:30 AM - 30 Minutes
Real-World Data in Action: Strengthening Regulatory Safety Decisions
Mircea Ciuca
Global Head Medical Safety
Organon
09:30 AM - 10:00 AM - 30 Minutes
Unlocking Patient Potential in Pharmacovigilance
Mayssa Aboughannam
Director, Risk Management Lead, Hematology
Johnson & Johnson
10:00 AM - 10:30 AM - 30 Minutes
Leveraging Big Data for Adverse Drug Event Identification and Interaction Detection
- Utilization of big data sources can transform the landscape of adverse drug event identification and drug interaction detection in pharmacovigilance.
- The ways in which big data analytics can provide deeper insights, predictive capabilities, and early warning signals for adverse drug events, ultimately leading to improved patient safety.
- The role of big data in uncovering complex drug interactions, including polypharmacy and co-morbidities, to better inform healthcare providers and improve medication management for patients.
10:30 AM - 10:50 AM - 20 Minutes
Business Card Exchange with Morning Coffee/Tea & Discussion
Network over morning coffee or tea, exchanging business cards or using our app's QR code scanner for easy contact sharing. A prime moment for engaging discussions and new connections
10:50 AM - 11:20 AM - 30 Minutes
High-Impact Collaborations in Pharmacovigilance: Strategies for ValueBased Partnerships
- Focusing on establishing a mutual understanding of the objectives and expected outcomes of the partnership to ensure aligned efforts and maximized value.
- The importance of defining clear roles and responsibilities for each partner to foster effective collaboration and accountability in pharmacovigilance activities.
- The key elements in negotiating and formalizing agreements that lay the foundation for successful, long-term partnerships in pharmacovigilance.
- Approaches for continuous monitoring and evaluation of the partnership’s performance to ensure it meets the evolving needs and goals of pharmacovigilance.
Mukesh Gori
Director Patient Safety & Pharmacovigilance ESP Engagement
Novartis
11:20 AM - 11:50 AM - 30 Minutes
Re-designing of Pharmacovigilance system to augment patient safety
Raghda Mohamed
Patient Safety Cluster Lead - Middle East and Turkey / Global patient Safety Evaluation
Takeda
11:50 AM - 12:20 PM - 30 Minutes
Outsourcing safety activities: strategic partnership or a numbers game?
- What is partnership? the mistake of calling a numbers game a partnership
- The benefits that could come from partnership and the challenges to developing true partnership
- Can those challenges be overcome?
- Can a numbers game be a better strategy than a partnership?
Annette Humes
Global Head of Safety Resource & Alliance Management and Chief of Staff (Safety)
Roche
12:20 PM - 12:50 PM - 30 Minutes
Panel Discussion - The Future of Pharmacovigilance: Balancing Innovation, Compliance, and Patient Safety
- The transformative impact of AI and automation on drug safety practices
- Preparing for advanced therapies like personalized medicine and biologics
- Strengthening patient engagement and transparency in pharmacovigilance processes
- Strategies for building resilient systems to navigate future challenges
Amit Jadhav
Director Global Patient Safety, Gene therapy I General medicine
Regeneron
Mircea Ciuca
Global Head Medical Safety
Organon
12:50 PM - 13:30 PM - 40 Minutes
Luncheon & Networking - Visit Exhibitor Booths & Network with your peers in our Lounge
Enjoy a luncheon while networking with peers and exploring exhibitor booths. This is an ideal time to engage with industry leaders, delve into innovative solutions, and forge valuable connections in a collaborative atmosphere.
13:30 PM - 14:00 PM - 30 Minutes
Covering the digitalization, regulatory requirements, and the importance of data integrity in being inspection-ready
Sandra Poel-Smet Van Der
Head of Safety Quality Management
UCB
14:00 PM - 14:30 PM - 30 Minutes
Harmonizing Pharmacovigilance Agreements: Strategies for Global Compliance and Operational Excellence
Azza Farouk Elgharably
Associate Director, Patient Safety Scientist
AstraZeneca
14:30 PM - 15:00 PM - 30 Minutes
Advancing Benefit-Risk Assessment Strategies: Lessons from Novel Therapies in Autoimmune and Rare Diseases
Remco M
Sr. Dir. Lead Global Safety Officer Immunology & Inflammation
Sanofi
15:00 PM - 15:30 PM - 30 Minutes
Improving Drug Safety Through Adverse Event Detection with Natural Language Processing (NLP)
- The transformative impact of Natural Language Processing (NLP) on the efficiency and accuracy of adverse event detection in pharmacovigilance.
- How NLP techniques can convert unstructured textual data from sources like medical records, social media, and patient narratives into actionable insights for drug safety monitoring.
- The challenges, such as data quality and privacy concerns, as well as the opportunities presented by NLP in improving drug safety, including early signal detection and more precise risk assessment.
15:30 PM - 15:50 PM - 20 Minutes
Grab your Tea/Coffee - Visit our Exhibitor Booths & Network with your colleagues
Refresh with a tea or coffee break, using this time to continue networking. It's a perfect opportunity to discuss ideas, share experiences, and connect with fellow attendees in a relaxed setting.
15:50 PM - 16:20 PM - 30 Minutes
Creating and Implementing a Global Signal Management Tool
David Jones
Director
Pfizer
16:20 PM - 16:50 PM - 30 Minutes
How to Ensure PV Compliance and Oversight Across Countries with Different Rules?
- Providing strategic input for the setup and maintenance of PV activities during geographical expansion.
- Establishing and maintaining PV processes to ensure compliance and oversight across diverse regulatory environments.
- Ensuring effective oversight of PV activities through collaboration with internal departments, affiliates, and external partners (e.g., business partners, PV vendors).
Giuseppe Violante
Associate Director, PV System Governance & Intelligence
Jazz Pharmaceuticals
16:50 PM - 17:20 PM - 30 Minutes
Elevating Drug Safety: The Crucial Role of Quality Case Processing in Pharmacovigilance
- How quality case processing serves as the cornerstone of pharmacovigilance, ensuring that adverse events are accurately and comprehensively captured, assessed, and reported.
- Impact of quality case processing on patient safety and public health, emphasizing its role in identifying and mitigating risks associated with pharmaceutical products.
- The need for ongoing training, process refinement, and the adoption of best practices in case processing to ensure the highest level of data quality and accuracy in pharmacovigilance activities.
17:20 PM - 17:50 PM - 30 Minutes
Development and implementation of Additional Risk Minimisation Measures
Amit Jadhav
Director Global Patient Safety, Gene therapy I General medicine
Regeneron
17:50 PM - 18:00 PM - 10 Minutes
Chairperson’s Closing Remarks & End of Conference
End the conference with the Chairperson's closing remarks, summarizing key insights and leaving attendees with final thoughts to inspire ongoing engagement and action.
Who Should Attend
C-level, Presidents, Senior/Global Vice Presidents, Directors, Directors, Heads & Managers, Scientific Advisors, Consultants and professionals who work for pharmaceutical, biotechnology & devices industries, CROs and service providers involved in Pharmacovigilance and Drug safety.
- Pharmacovigilance
- Safety & Risk management
- Drug safety
- PV Compliance
- Safety Surveillance
- Medical Affairs
- Regulatory Affairs
- Inspection and Audit
- Pharmacoepidemiology
- Post-market studies
- Medical product safety assessment
- Drug Research & Development
- Clinical Pharmacology
- Medical information
- Contract outsourcing service providers
- Health outcomes
- Sales and Marketing
Location
ADDRESS
Hilton London Kensington
179-199 Holland Park Ave
London
W11 4UL
United Kingdom
