Human in the Loop

In this episode, I speak with Daniel Kapfer, CEO of Jenly AI, about how AI is reshaping regulatory reporting and PV processes. We discuss real use cases, quick efficiency wins, and the risks you can’t ignore, including AI hallucinations and validation challenges.The key message: AI can accelerate pharmacovigilance, but humans remain essential. The future is “human in the loop.”What you’ll learn:• Where AI delivers the biggest impact in PV• How to use tools like Copilot for quick wins• How to manage AI risks and hallucinations• Why human expertise is still critical📩 Contact Daniel Kapfer:Website: www.jenly.aiEmail: [email protected]

In this episode of The Pharmacovigilance Podcast, host Julia Appelskog speaks with Sabita Mukherjee, COO and Joint Owner, Essjay Solutions Ltd & Sagittal Pharma Consulting Ltd.Sabita shares his unusual career journey from more than 30 years in financial services to working in pharmacovigilance. Drawing on experience from two highly regulated industries, he discusses how governance, accountability, audits, and crisis management. The conversation also explores the growing role of AI in regulated environments. Sabita and Julia discuss why explainability, human oversight, and strong governance are essential when adopting AI in pharmacovigilance, and how regulators are encouraging innovation while maintaining patient safety.Topics covered:• Career transition from finance to pharmacovigilance• Differences in regulatory culture between finance and PV• Governance and accountability in AI systems• AI as a “copilot” rather than an “autopilot”• Audits, explainability, and decision transparency• Crisis management in regulated industriesA thoughtful conversation on how different regulated sectors can learn from each other and how AI can support professionals without replacing expert judgment.🎧 Stay tuned and stay compliant.Guest: Sabita Mukherjee, COO and JointOwner, Essjay Solutions Ltd & Sagittal Pharma Consulting LtdEssjay Solutions Ltd:  https://essjaysolutions.co.uk/LinkedIn: https://www.linkedin.com/company/essjay-solutions-ltd/Subscribe to AI in PV Newsletter Subscription Page: https://mailchi.mp/b65dd5bfa504/essjay_ai_newsletterSagittal Pharma Consulting Ltd: https://sagittal-pharma.com/LinkedIn: https://www.linkedin.com/company/sagittalpharmaconsulting/YouTube: https://www.youtube.com/@sagittalpharma

New episode of The Pharmacovigilance PodcastGuests: Romain Clément and Olivier Merle from ArcaScienceBenefit–risk assessment is at the core of pharmacovigilance. More data, faster development timelines, increasing complexity, and rising expectations from regulators andLeadership is challenging traditional approaches that rely heavily on manual review and retrospective analysis.In this new episode, we explore how AI is reshaping benefit–risk decision-making and what this means for senior safety professionals today.Together with experts from ArcaScience, we discuss:What AI actually changes in day-to-day benefit–risk workHow integrated data supports earlier and more confidentdecisionsHow ArcaScience models support benefit–risk acrossdevelopment stagesHow regulators are reacting to AI-supported approachesThis conversation focuses on practical realities and on how safety teams can use AI to strengthen expertise, not replace it.🔗 Learn more & connectArcaScience website: https://arcascience.aiRomain Clément on LinkedIn: https://www.linkedin.com/in/romainclement75/Olivier Merle: https://www.linkedin.com/in/oliviermerle/ArcaScience on LinkedIn: https://www.linkedin.com/company/arcascience/▶️ SubscribeFollow The Pharmacovigilance Podcast on Spotify to stay updated on new episodes covering AI, safety leadership, regulatory thinking, and the future of pharmacovigilance.

In this episode of The Pharmacovigilance Podcast, we go inside modern PV quality systems and explore how organisations can move from reactive QMS models to proactive, AI-supported audit frameworks.I’m joined by Stephanie Martin, Founder of SMPV Limited and a global PVQA audit expert with extensive experience supporting pharma and biotech companies through audits and inspections worldwide.Together, we discuss:Why traditional, reactive QMS models no longer workWhat regulators really expect from PV quality systems todayHow to build inspection-ready, sustainable PV processesThe role of AI in supporting audits, oversight, and continuous improvementPractical steps to strengthen PV quality without disrupting daily safety activitiesThis episode is for PV leaders, QA professionals, and anyone preparing for inspections as they navigate the future of pharmacovigilance quality.Link to the LinkedIn profile of Stephanie Martin, Founder of SMPV Limited: https://www.linkedin.com/in/stephaniesmpv/

In this episode #20 of The Pharmacovigilance Podcast, host Julia Appelskog sits down with Dr. Stephanie Jones, Founder & Chief Medical Officer of Pharmora, to trace her path from independent consultant to leading a high‑performing medical services company supporting clinical development and pharmacovigilance worldwide. We discuss early pivots, the leadership habits that scale quality, and why “quality without compromise” became a guiding principle for sustainable growth. We also explore how to build a values‑aligned team, deliver consistently under pressure, and win trust as a specialist partner in lifecycle safety and medical review. Pharmora was founded in 2010 and today serves the global pharma and biotech sectors. In 2025, the company was recognised in London’s Gherkin with the Best Pharma Contract Services award at the IAE & Euro Star Global Awards, an emotional milestone for the team and a practical lesson in long‑game execution.You’ll learn:• How to move from freelancing to a scalable service model in pharma• The operational meaning of “quality without compromise” and why it compounds over time• Hiring for values, training for excellence, and building delivery capacity that clients rely on• Advice, pitfalls, and playbooks for would‑be founders in PV, clinical, and medical affairsLinksDr. Stephanie Jones — LinkedIn profile linkedin.com/in/stephanie-j-jonesPharmora Pharmora | Clinical Development support | PharmacovigilanceIAE & Euro Star Global Awards announcement (The Gherkin, 2025) IAE Awards post

What’s the one thing about MedDRA that most people overlook?That’s where this episode #19 of The Pharmacovigilance Podcast begins. It’s a privilege to feature a thoughtful and insightful conversation with Vitali Chevts, one of the field’s most respected MedDRA experts and a member of the ICH MedDRA Steering Committee.This discussion is a reminder of why this work matters — clear thinking, deep expertise, and a shared commitment to getting safety data right.🎙️ In this episode, we cover:• Why MedDRA is far more than a coding tool• Subtle errors that can reshape an entire safety story• How CMQs can strengthen AE monitoring• What actually happens inside the MedDRA Steering Committee• The role of AI — and the boundaries we need to respectWith more than 25 years of experience, Vitali brings clarity, nuance, and practical insight to every topic we touch.Links: ICH MedDRA Steering Committee⁠https://www.ich.org/page/meddra-steering-committee⁠Vitali Chevts on LinkedIn: https://www.linkedin.com/in/vitali-chevts-md/

In this episode, we explain one of the most important guideline updates of the decade: the revision and implementation of ICH E2D(R1) on post-approval safety data management. The original guideline from 2003 could no longer keep up with the rise of digital platforms, patient support programs, market research programs, and the massive increase in safety data.E2D(R1) changes that. It introduces modern definitions, clearer responsibilities for MAHs, and a new foundation for structured safety data activities through the Organised Data Collection System (ODCS). We also look at how the guideline aligns with E2B(R3), including the three new study-type values for coding cases from PSPs, MRPs, and digital platform activities.You’ll learn:• why this revision was needed• how new data sources are classified• what ODCS really means in practice• how to distinguish spontaneous vs. solicited reports• what changes MAHs should expect in E2B(R3) reportingIf you work in drug safety, regulatory intelligence, or PV operations, this episode gives you the clarity you need to prepare for the 2026 implementation.Link to ICH E2D(R1) guideline: https://database.ich.org/sites/default/files/ICH_E2D%28R1%29_Step4_FinalGuideline_2025_0819.pdf

In this episode, we discuss the new auditing requirements in pharmacovigilance and how risk-based auditing is transforming the way companies conduct their operations. Our guest, Pankaj Nautiyal, is a pharmacovigilance expert with over 18 years of experience in global pharmacovigilance compliance and PV auditing. We discuss:• What risk-based auditing really means• How the new regulation affects MAHs and subcontractors• What needs to change in audit plans, contracts, and quality systems• Practical tips to stay compliant without over-auditingConnect with Pankaj on LinkedIn: https://www.linkedin.com/in/pankaj-nautiyal-b5565912/Read the regulation here: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32025R1466

In this episode, host Julia Appelskog discuss with Dr. Calin Lungu, a pharmacovigilance expert with two decades of experience working with EMA systems such as EudraVigilance, EVDAS, and the Extended Medicinal Product Dictionary (XEVMPD). Together, they unpack the complexities of Article 57 requirements, XEVMPD data, and the transition towards PMS (Product Management Services).You will learn:Why XEVMPD (Article 57 data) is critical for regulators, MAHs, and clinical trial sponsors.How data interconnects across EMA platforms like PMS, OMS, and IRIS.Practical insights for marketing authorization holders on managing submissions, business operations, pack size descriptions, and shortages reporting.Common challenges with QPPV and PSMF updates and how to handle them effectively.What’s changing in 2025 and how organizations should prepare.Dr Lungu also shares training resources and advice for MAHs.Links to Dr. Calin Lungu's profile: linkedin.com/in/calin-lungu-2b613a7

In this episode of The Pharmacovigilance Podcast, we explore how Contract Research Organizations (CROs) are reshaping their strategies in today’s AI-driven landscape. With rapid advancements in technology and AI, CROs face both challenges and opportunities as they adapt to new business models.Our guest, Lindsay Mateo, shares expert insights on:How AI is transforming traditional CRO operationsPractical steps for implementing AI tools in clinical researchThe evolving role of data in driving smarter, faster decision-makingWhat the future CRO playbook looks like for sponsors and partnersFollow The Pharmacovigilance Podcast to stay ahead of the curve in drug safety, regulatory science, and healthcare innovation.Guest: Lindsay Mateo, Chief Commercial Officer of AI-native regulatory platform Weave BioLinkedIn: https://www.linkedin.com/in/lindsay-mateo-mba-72aa5b12/https://www.weave.bio/