Graeme Ladds | CEO
PharSafer
With a first degree in Biochemistry and Pharmacology, and a PhD 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 Head of Global Pharmacovigilance for a multinational innovator company, and as EU QP PV for several top ten pharmaceutical companies, large generics and smaller innovative pharma organisations, Graeme is the CEO and Owner of PharSafer® — a position held for the last 23 years. During this time, he has taken many products from bench to clinical development and through to post-marketing in multiple global markets, helping small start-up companies (biotech, advanced therapy, medical device, biologic, generics, herbal and OTC) with planning and growth, due diligence for product in-licensing and marketing, and development strategies with partner and distributor companies. Graeme has also been involved in numerous global audits (conducted) and inspections (participated in) for clients, as well as database design and development projects that have been commercialised.
Appearances:
Day 1: 17th March 2026 @ 16:30
The Safety Journey for Advanced Therapies – Innovation Over Effort
Objectives:
- Recognise why traditional pharmacovigilance models are often poorly aligned with the realities of advanced therapies.
- Understand where safety activities can create disproportionate effort without improving compliance or data accuracy.
- Evaluate how innovation-led approaches, including automation and streamlined workflows, can support complex modalities and small, diverse patient populations.
- Take away practical considerations for building scalable, compliant safety frameworks across the product lifecycle long-term.
Abstract:
Advanced therapies are redefining what good patient safety oversight looks like. Novel mechanisms of action, long-term risk potentials and limited clinical exposure place pressure on pharmacovigilance models that were built for products having a pharmacological activity, whilst regulatory expectations are evolving to accommodate such new scientific breakthroughs.
This session follows the safety journey of advanced therapies and challenges the assumption that stronger oversight requires more intense effort. Instead, it explores how innovation-led approaches, including automation, smarter workflows, and proportionate safety design can simplify operations, strengthen compliance, enhance data accuracy and support accelerated development without compromising patient safety.
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