Graeme Ladds | CEO
PharSafer
With a first degree in Biochemistry and Pharmacology, and a Ph.D. focusing on drug metabolism and Pharmacokinetics, Graeme has worked in the areas of Drug Safety and Medical services for over 35 years.
Having worked as a Head of Global Pharmacovigilance for a multi-national innovator Company and EU QP PV for several of the top ten Pharma Companies, large generic and smaller innovative Pharma, Graeme is the CEO and Owner of PharSafer® – a position held for the last 21 years – and has taken many products from bench to clinical to post-marketing in many global markets; helping many small start-up Companies (Biotech, Advanced Therapy, Medical Device, Biologic, Generics, Herbal, OTC) in their planning and growth, due-diligence activities for product in-licensing and marketing, and development strategies with partner and distributor Companies.
Graeme has also been involved in many global audits (conducted) and inspections (taken part in) for clients and also database designs and development that have been commercialised.
Appearances:
Day 1 - World Drug Safety Congress Americas 2025 @ 11:20
Presentation: Automation in Pharmacovigilance – Friend or Fiend
Automation is already reshaping pharmacovigilance — quietly, compliantly, and effectively. This session explores why automation, not AI, is the real innovation in safety-critical workflows. We’ll discuss regulatory expectations, current use cases, and how rule-based systems deliver reliable, auditable results. Whilst AI remains aspirational, automation is operational — and inspection-ready!
Objectives include:
- Understand the key differences between automation and AI in pharmacovigilance.
- Learn where automation is already successfully used in PV processes.
- Explore regulatory expectations around validated systems and inspection readiness.
- Assess risks of unvalidated AI versus the compliance benefits of automation.
- Discover how hybrid models can balance automation with human oversight.
Sponsored by PharSafer.
Day 1 - World Drug Safety Congress Americas 2025 @ 12:20
Panel: Beyond Cost: Reclaiming Quality in Pharmacovigilance Outsourcing
As outsourcing in pharmacovigilance accelerates, how do we ensure patient safety isn’t compromised by cost-driven decisions? This panel explores the role of QA and QMS in the vendor selection process, making the case for pre-qualification audits and robust quality metrics before contracts are signed.
Join our thought leaders to debate how we can embed quality from the outset — and why PV QA voices must be central to outsourcing strategy.
The objectives of this panel discussion will:
- Examine how QMS and KPIs can guide the selection and oversight of outsourced PV vendors.
- Discuss the growing need for robust pre-qualification audits — not just post-selection oversight.
- Debate whether cost is driving outsourcing decisions at the expense of quality.
- Explore how QA teams can influence vendor selection with risk-based, patient safety–focused criteria.
- Share strategies to embed quality metrics early in the decision-making process, not retrospectively.
Sponsored by PharSafer.
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Emily Ngai
emily.ngai@terrapinn.com
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