The Safety Journey for Advanced Therapies – Innovation Over Effort
Information
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.
