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The Pharmacovigilance Podcast

Julia Appelskog
Pharmacovigilance
Artificial Intelligence
Patient Safety
Clinical Trials
Risk Management Plans
ICH E6(R3)
Data Privacy
Artificial Intelligence Act
EMA Guidance
Anonymisation
Commercially Confidential Information
Iris
Ethics In AI
Human Oversight
Post-Market Surveillance
Risk-Based Monitoring
Data Integrity
AI Regulation
Transparency In AI
United Kingdom

The Pharmacovigilance Podcast is your gateway to understanding how technology, regulation, and innovation converge to safeguard patient safety. Our discussions span legislative updates and the practical application of AI in pharmacovigilance workflows. Stay ahead of the curve with The Pharmacovigilance Podcast, where safety meets innovation.

PublishesMonthlyEpisodes24Founded2 years ago
Number of ListenersCategories
MedicineHealth & Fitness

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Artwork for The Pharmacovigilance Podcast

Latest Episodes

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 validatio... more

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 fina... more

New episode of The Pharmacovigilance Podcast

Guests: Romain Clément and Olivier Merle from ArcaScience

Benefit–risk assessment is at the core of pharmacovigilance. More data, faster development timelines, increasing complexity, and rising expectati... more

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 Lim... more

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Recent Guests

Daniel Kapfer
CEO of Jenly AI
Jenly AI
Episode: Human in the Loop
Sabita Mukherjee
COO and joint owner of Essjay Solutions; COO of Sagittal Pharma Consulting
Essjay Solutions; Sagittal Pharma Consulting
Episode: From Finance to Pharmacovigilance: Lessons from Two Regulated Worlds
Olivier Merle
Pharmacologist with 25 years in the industry
ArcaScience
Episode: Transforming Benefit-Risk Assessment with AI
Romain Clément
Co-founder, AI scientist and data engineer at ArcaScience; former GSK data management lead
ArcaScience
Episode: Transforming Benefit-Risk Assessment with AI
Stephanie Martin
Managing Director of SMPV Limited
SMPV Limited
Episode: Inside PV Quality System: From Reactive QMS to AI-Supported Audits
Stephanie Jones
Chief Medical Officer of Pharmora
Pharmora
Episode: From Freelancer to Award-Winning Founder: How to Build a Thriving Business in Pharma
Vitali Chevts
Medical Coding Strategy Lead at Merck KGIA
Merck KGIA
Episode: MedDRA Matters: Behind the Scenes of International Standards
Pankaj Natiyal
Pharmacovigilance auditor for Baxter Pharmaceuticals
Baxter Pharmaceuticals
Episode: Risk-Based Auditing in Pharmacovigilance: What Changes with EU Regulation 2025/1466?
Calin Lungu
Medical doctor with extensive EMA system experience including EudraVigilance and XEVMPD
Independent auditor; EMA systems expert
Episode: Inside XEVMPD: Data, Safety and Strategy

Host

Julia Appelskog
Host with multiple episode appearances; central figure in PV discussions

Reviews

4.4 out of 5 stars from 11 ratings
  • AI Generated content?

    This podcast definitely sounds like two AI generated personalities talking to each other and not real people. Way too polished delivery, scripted spontaneity, no real personality or human touch. It comes across as a training you could generate using NotebookLM and is hard to listen to as a result…

    Apple Podcasts
    2
    Human Being Here
    Switzerland3 months ago

Listeners Say

Key themes from listener reviews, highlighting what works and what could be improved about the show.

Some listeners feel the delivery is overly polished and scripted, lacking spontaneity.
Positive notes often highlight practical AI insights and governance-focused discussions.
A few guests are highly technical; newcomers may need time to acclimate to the terminology.

Chart Rankings

How this podcast ranks in the Apple Podcasts, Spotify and YouTube charts.

Talking Points

Recent interactions between the hosts and their guests.

What Changed for UK Medicines After the Windsor Framework?
Q: What are the current expectations for the UK PSMF vs the EU PSMF, and is a single document possible?
A single document is possible if UK annexes are robust; however, many companies maintain a stand-alone UK PSMF or a modular/global PSMF with country-specific annexes to reflect regional responsibilities and ensure clarity across inspections.
What Changed for UK Medicines After the Windsor Framework?
Q: Can you explain a little bit how the UK and Northern Ireland now align or differ in regulation under the Windsor Framework?
The Windsor Framework separates the Great Britain and Northern Ireland regimes for medicinal regulation, leading to UK-wide licenses that cover GB and NI, while some situations still require adherence to EU legislation, hence portfolio categorization into category one (centralized scope in MHRA) and category two (EU-legislation applicable).
The new CRO Business Playbook in the Age of AI
Q: What does the pricing model look like as adoption grows?
The discussion highlights a shift toward value-based pricing and technology fees, where faster delivery and expanded capabilities can open opportunities for new projects even if total hours decrease.
The new CRO Business Playbook in the Age of AI
Q: How does the platform ensure data integrity and avoid relying on potentially unreliable public-domain information?
The system confines AI-generated content to the material uploaded in the customer's data room, with a robust data verification step that links each sentence back to its exact source files, ensuring traceability and accuracy.
The new CRO Business Playbook in the Age of AI
Q: How is the regulatory process changing with AI, and who benefits from it?
AI accelerates content creation, formatting, and verification, allowing regulatory writers to focus on narrative quality while ensuring accuracy and compliance through structured data. This benefits pharmaceutical companies, CROs, and regulatory operations teams by reducing time to submission and increasing consistency across regulators.

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Frequently Asked Questions About The Pharmacovigilance Podcast

What is The Pharmacovigilance Podcast about and what kind of topics does it cover?

The show concentrates on how technology, regulation, and AI are transforming pharmacovigilance and safety reporting. Episodes frequently explore AI-enabled workflows, regulatory updates, data standards like MedDRA and XEVMPD, and practical strategies for implementing AI in PV—from human-in-the-loop approaches to governance and audits. Guests tend to include regulatory and industry experts, CROs, QA leads, and AI/tech practitioners who bring hands-on insights into how to modernize safety operations while maintaining patient protection. A standout throughline is balancing innovation with rigorous compliance, making it useful for listeners responsible for safety data, submissions, and vendor management across highly regulated environments.

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How many listeners does The Pharmacovigilance Podcast get?

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How many subscribers and views does The Pharmacovigilance Podcast have?

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Which podcasts are similar to The Pharmacovigilance Podcast?

These podcasts share a similar audience with The Pharmacovigilance Podcast:

1. TED Talks Daily
2. Como Assim

How many episodes of The Pharmacovigilance Podcast are there?

The Pharmacovigilance Podcast launched 2 years ago and published 24 episodes to date. You can find more information about this podcast including rankings, audience demographics and engagement in our podcast database.

How do I contact The Pharmacovigilance Podcast?

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What guests have appeared on The Pharmacovigilance Podcast?

Recent guests on The Pharmacovigilance Podcast include:

1. Daniel Kapfer
2. Sabita Mukherjee
3. Olivier Merle
4. Romain Clément
5. Stephanie Martin
6. Stephanie Jones
7. Vitali Chevts
8. Pankaj Natiyal

To view more recent guests and their details, simply upgrade your Rephonic account. You'll also get access to a typical guest profile to help you decide if the show is worth pitching.

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