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Drug Safety Matters

Uppsala Monitoring Centre

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Drug Safety Matters brings you the best stories from the world of pharmacovigilance. Through in-depth interviews with our guests, we cover new research and trends, and explore the most pressing issues in medicines safety today. Produced by Uppsala Monitoring Centre, the WHO Collaborating Centre for International Drug Monitoring. The views and opinions expressed in the podcast are those of the hosts and guests respectively and, unless otherwise stated, do not represent the position of any ins ...
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"Innovation and the Future of Pharmacovigilance" is a podcast series under our Truliant Talks platform. We dive into the fascinating world of drug safety, exploring ongoing challenges, cutting-edge technology, and future predictions in pharmacovigilance. Our expert guests provide a wealth of knowledge as they discuss topics from real-world data to post-marketing surveillance, ethical considerations, and beyond. This podcast is an invaluable resource for anyone interested in understanding how ...
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The pace of change in healthcare is accelerating. Our understanding of how data, technology and scientific expertise can come together is only getting more precise. In this podcast, leaders from IQVIA lead discussions on the issues, innovations, and collaborations that are making an impact on health and business outcomes. Topics will include new approaches to clinical development, leading-edge technologies and methodologies that extract more value (and less work) from healthcare data, and st ...
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Welcome to the International Pharma Talks, powered by ELS Solutions Group, a podcast hosted by Dr. Diogo Sousa-Martins, Ph.D., MBA. This podcast will dive deep into the world of pharma & healthcare international business where you will learn strategies and action plans to help you navigate through your internationalization program and achieve the best results. If you wish to develop your international program in pharma, healthcare or medtech areas or to register or distribute your products i ...
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New podcast weblog“AI Revolution in Healthcare: A Regulatory Perspective with Dr. Nirdosh Jagota” is your gateway to understanding the intersection of artificial intelligence and healthcare regulation. Hosted by Dr. Nirdosh Jagota—a seasoned expert with over 30 years in the biotech and pharmaceutical sectors—this podcast explores how AI is reshaping every aspect of healthcare, from drug discovery to patient care, and the regulatory frameworks that support this transformation. In each episode ...
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Far from a future add-on, artificial intelligence is already embedded in the cycle of drug safety, from case processing to signal detection. Versatile generative AI models have raised the bar of possibilities, but they have also increased the stakes. How do we use them without losing trust and where do we set the limits? In this two-part episode, N…
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Welcome to “Debunking Value, Access & Pricing Myths”—a podcast series from IQVIA’s Value and Payer Evidence team where we explore the transformations underway in healthcare pricing and market access - challenging outdated norms and shedding light on the new realities shaping our work. In the second episode, your host Rebecca Coady, Principal at IQV…
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How Efficiency in Import and Distribution Logistics Drives Global Success? Efficient importation and distribution are no longer operational afterthoughts, they are strategic imperatives for pharmaceutical and MedTech companies seeking global expansion. But what are the hidden risks, and how can companies truly optimize their logistics while remaini…
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Children deserve the safest possible healthcare, yet they remain one of the most vulnerable patient populations when it comes to medicines safety. Ahead of World Patient Safety Day on 17 September, we discuss challenges and solutions in paediatric pharmacovigilance with ISoP president Angela Caro-Rojas. Tune in to find out: Why we need a Patient Sa…
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This episode focuses on how Agentic AI is shaping the future of clinical research. In this episode you will: Learn about the differences between an AI agent and an agentic framework and how the latter can coordinate and orchestrate many different AI agents to answer more complex questions. Explore the capabilities of Agentic AI and its applications…
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Artificial Intelligence is Reshaping Pharmacovigilance – But Are You Ready? With over 1.5 million adverse drug reactions reported annually in the EU alone, the pressure on pharmacovigilance systems has never been greater. Could artificial intelligence (AI) be the answer? In this episode of International Pharma Talks, Dr. Diogo Sousa-Martins, Founde…
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Welcome to “Debunking Value, Access & Pricing Myths”—a podcast series from IQVIA’s Value and Payer Evidence team where we separate fact from fiction on some of the most persistent misconceptions in the world of healthcare pricing and access. In this debut episode, your host Rebecca Coady, Principal at IQVIA, is joined by her colleague and EU HTA ex…
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This special episode was recorded at the mid-year symposium of the International Society of Pharmacovigilance (ISoP), 14–15 May 2025. Held in Uppsala, Sweden, the theme of the symposium was Improving information capture for safer use of medicines. The episode is an abridged recording of the concluding fireside chat, where Angela Caro-Rojas (preside…
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This episode focuses on how IQVIA is innovating with agentic AI to drive efficiency and quality in clinical trials. In this episode you will: Discover how agentic AI can be leveraged to enhance efficiency and quality in clinical trials and help increase the chance of success. See how an agentic AI approach can optimize site selection, trial design,…
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Spontaneous adverse event reporting from healthcare professionals and patients is a cornerstone in pharmacovigilance systems. Unfortunately, it is a well-known issue that only a fraction of events is reported. To further complicate matters, poor quality reports present a significant challenge for pharmacovigilance assessors. In Uganda, several new …
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This podcast features malaria experts Caroline Boulton (Global Program Head, Malaria, at Novartis); Sherwin Charles (CEO, Goodbye Malaria); and Carlos Chaccour (Researcher and Visiting Scholar, Navarra Institute for International Development). The conversation delves into the current malaria response, examining shifts in international funding, R&D …
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In this episode, IQVIA MedTech experts Michelle Edwards and Michaela Miller discuss key trends shaping the MedTech industry in 2025. The conversation covers advancements in 3D printing, real-world evidence (RWE), and clinical AI, among others. Read Ten MedTech Trends to Watch in 2025 to learn more. Host: Michaela Miller, Practice Lead, U.S. MedTech…
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This podcast episode features a discussion between Jeff Pilch from IQVIA and Sanjay Mistry from Molnlycke. Together, they explore the journey of how their companies collaborated to solve a significant business problem related to customer master data management (MDM). Sanjay explains the challenges Molnlycke faced in defining and managing customer d…
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There are many reasons why use of medical products during pregnancy requires special attention. First and foremost, we want to be sure that the medicine is as safe as possible for both the pregnant person and the unborn child. Unfortunately, the safety profiles of medicines used in pregnancy are often incomplete, which makes it difficult for patien…
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Brazil’s medicinal cannabis market is evolving rapidly, with more patients, new regulatory pathways, and a growing industry presence. But how accessible are these treatments, and what are the biggest challenges companies face? In this episode of International Pharma Talks, Dr. Diogo Sousa-Martins explores the business and regulatory landscape of me…
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On International HPV Awareness Day, Dr. Nicola Paul hosts Dr. Tando Gaqana, a passionate HPV vaccine advocate, and Daniel Mora-Brito, IQVIA's thought leader in global health, to discuss the impact of Human Papillomavirus (HPV) in South Africa, highlighting the importance of vaccination and regular screening to prevent HPV-related conditions in Afri…
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The pharmaceutical market is constantly evolving,shaped by innovation, shifting demands, and regulatory developments. In this episode of International Pharma Talks, our host, Dr. Diogo Sousa-Martins explores how the industry is changing and what these transformations mean forthe future. Tune in to discover: How technology is reshaping drug developm…
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In the season finale of AI Revolution in Healthcare: A Regulatory Perspective, Dr. Nirdosh Jagota reflects on the future of AI in healthcare, looking ahead to 2030 and beyond. This episode brings together key themes from the series to explore how healthcare innovation, regulatory frameworks, and patient safety will evolve in the years to come. Dr. …
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In this thought-provoking episode of AI Revolution in Healthcare: A Regulatory Perspective, Dr. Nirdosh Jagota explores the vital topics of ethics and patient privacy in AI-powered healthcare systems. As AI becomes increasingly involved in medical decision-making, issues such as accountability, transparency, and fairness take center stage. Dr. Jago…
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In this episode of AI Revolution in Healthcare: A Regulatory Perspective, Dr. Nirdosh Jagota examines the global regulatory landscape for AI in healthcare. As AI technologies transcend borders, understanding the similarities and differences between regulatory frameworks is critical for innovators seeking worldwide implementation. Dr. Jagota explore…
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In this episode of AI Revolution in Healthcare: A Regulatory Perspective, Dr. Nirdosh Jagota explores the vital process of validation and verification for AI systems in healthcare, emphasizing their role in ensuring safety and effectiveness for patient care. Dr. Jagota breaks down the unique challenges AI systems present compared to traditional med…
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In this episode of AI Revolution in Healthcare: A Regulatory Perspective, Dr. Nirdosh Jagota dives into the transformative role of artificial intelligence in drug safety and pharmacovigilance. With the ability to process thousands of adverse event reports daily, AI is reshaping how pharmaceutical companies identify and respond to safety signals, en…
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What does the future look like for the pharma industry in 2025? Join Dr. Diogo Sousa-Martins in our latest episode of International Pharma Talks, where he explores the key trends shaping the pharmaceutical landscape this year. With rapid advancements in AI, regulatory changes, and the growing importance of personalized medicine, staying ahead has n…
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This episode focuses on using AI for indication selection and prioritization to optimize the value of clinical development planning. In this episode you will: Discover how AI can identify indications with the greatest probability of success and areas of untapped opportunity. See how AI can be leveraged to prioritize hundreds of indications into hig…
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Human and veterinary pharmacovigilance (PV) share many goals, challenges and approaches. But there are also significant differences, such as the numerous animal species that veterinary PV needs to take into account. In this two-part episode of Drug Safety Matters, James Mount, Veterinary Pharmacovigilance assessor at the Swedish Medical Products Ag…
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In the 37th episode, our host, Dr. Diogo Sousa-Martins delves into the dynamic and rapidly evolving cannabis market in Europe, analyzing how the regulatory frameworks, market trends, and societal implications works in this controversial yet very promising industry. From the rise of medical cannabis markets in Germany, Poland, the Czech Republic, an…
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In this episode, Dr. Vishakha Sharma, Senior Principal Data Scientist at Roche Diagnostics shares her perspectives on the potential of GenAI to improve patient outcomes, enhance the efficiency of healthcare delivery, and reduce costs. She also addresses some of the key issues surrounding data interoperability and data integration when dealing with …
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Send us a text Unlock the potential of the future in pharmacovigilance as we chart the transformative journey of the industry in 2024 and beyond. Discover how smaller companies are spearheading innovation by filling niche gaps, while larger players focus on comprehensive platform-level needs. Witness this dynamic balance creating a fertile environm…
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Join IQVIA Thought Leaders, Kirstie Scott and Stefan Lutzmayer, to explore how to translate the promise of ground-breaking oncology therapies into commercially successful launches. Learn about the evolving oncology landscape, and how to navigate a fluid and challenging commercial environment to achieve Oncology Launch Excellence.…
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Human and veterinary pharmacovigilance (PV) share many goals, challenges and approaches. But there are also significant differences, such as the numerous species and breeds that veterinary PV needs to take into account. In this two-part episode of Drug Safety Matters, James Mount, Veterinary Pharmacovigilance assessor at the Swedish Medical Product…
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While structured data elements such as patient identifier, medicine name and reaction, are fundamental for adverse event reporting, they may not capture all relevant details. This is where the narrative fields come in, allowing reporters to disclose important contextual information, such as the patient’s full clinical course. But how do PV assessor…
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In this episode of AI Revolution in Healthcare: A Regulatory Perspective, Dr. Nirdosh Jagota explores the innovative concept of Predetermined Change Control Plans (PCCPs) for AI and machine learning-enabled medical devices. PCCPs offer a regulatory solution to the challenge of managing evolving AI systems that learn and adapt over time. Dr. Jagota …
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In this episode of AI Revolution in Healthcare: A Regulatory Perspective, Dr. Nirdosh Jagota explores how artificial intelligence is transforming pharmaceutical manufacturing, particularly in quality control. Titled "Quality Control and AI: Ensuring Safety in Drug Manufacturing," this episode delves into the intersection of AI and regulatory compli…
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In this episode of AI Revolution in Healthcare: A Regulatory Perspective, Dr. Nirdosh Jagota explores the transformative role of machine learning in medical imaging and its regulatory journey. He highlights a Swedish study where AI-assisted breast cancer screening improved detection rates by 4% compared to traditional methods. Dr. Jagota examines t…
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In this episode of AI Revolution in Healthcare: A Regulatory Perspective, Dr. Nirdosh Jagota dives into the transformative role of artificial intelligence in clinical trials and drug development. Titled "Artificial Intelligence in Clinical Trials: Transforming Drug Development," Dr. Jagota discusses how AI is addressing critical challenges in clini…
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In the very first episode of "AI Revolution in Healthcare: A Regulatory Perspective," Dr. Nirdosh Jagota takes listeners on a journey to explore how artificial intelligence is transforming healthcare and what it means for regulatory processes. In this episode, titled "The Dawn of AI in Healthcare: Understanding the Regulatory Landscape," Dr. Jagota…
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Send us a text Marie Pihl’s journey from an assistant nurse with dreams of working in a children's hospital to becoming the Director of Operations, Technology, and Analytics in Global Patient Safety at AstraZeneca is nothing short of inspiring. Her story is one of perseverance, adaptability, and the power of commitment, as she balanced further educ…
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In this episode you will: Discover how AI can predict the success of clinical trials in terms of efficacy, regulatory approval, operational feasibility, reimbursement attainment and product uptake. Learn why AI can give us deeper insights by analyzing unstructured data for better-informed clinical development decisions. See how an agentic AI approa…
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Send us a text What can we learn from a leader at the forefront of pharmacovigilance and risk management? Thomas Kuckuk, Head of System Operations Management at Novartis, offers an insightful journey through his career, weaving through medical informatics and into the heart of the pharmaceutical industry. This episode promises to illuminate the dyn…
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Medication-related-harm (MRH) is especially prevalent in older adults due to changing physiology as the body ages, increased frailty, and the incidence of polypharmacy in this patient group. Giovanni Furlan, Worldwide Safety Site Lead for Thessaloniki of Pfizer discusses what makes this patient group so vulnerable to adverse drug reactions, how poo…
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Send us a text Sabura Matthews, a visionary in digital strategy for global patient safety, shares her transformative journey from the fast-paced world of trauma nursing to the strategic realm of pharmacovigilance. Her story begins amidst the chaotic energy of Philadelphia's trauma centers, where she honed her critical care skills. Facing profession…
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Send us a text What do you get when you combine a background in neurobiology with a serendipitous introduction to pharmacovigilance? Join us as Sibel Guerler, Head of Strategy and Safety Evaluation at BMS, takes us on her remarkable journey, where life's unexpected turns have led to a fulfilling career in drug safety. Transitioning from managing da…
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Disproportionality analyses are a mainstay of pharmacovigilance research, but without clear guidelines, they often lead to confusion and misinterpretation. Enter the READUS-PV statement: the first-ever guide for reporting disproportionality analyses that are replicable, reliable, and reproducible. Tune in to find out: The history of reporting guide…
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Tune in to the latest episode of the IQVIA SFE Insights Podcast as Lakshdeep Singh, Senior Principal at IQVIA, and Goksu Dogan, Senior Principal in the Artificial Intelligence and Machine Learning Solutions team, explore the role of predictive analytics and real-time triggers in optimizing HCP engagement and improving patient outcomes. Discover how…
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