Extractables & Leachables Analysis

This course is designed for analytical scientists, toxicologists, packaging and device engineers, regulatory affairs professionals, and pharmaceutical development teams seeking practical alignment with evolving E&L regulatory expectations across multiple drug product types.

The training focuses on current regulatory expectations, including ICH Q3E, and references key global standards such as EMA, FDA, USP, ISO, and EP to support consistent, inspection-ready E&L strategies.

Participants gain structured insight into risk-based approaches, linking extractables studies, leachables assessment, AET, and lifecycle risk management to support robust, defensible decision-making.

Yes, the programme covers a wide range of drug product types, including biologics, inhalation products, ADCs, and cell and gene therapies, addressing modality-specific E&L considerations.

The course reviews key analytical methods for volatile, semi-volatile, non-volatile, and inorganic compounds, focusing on method selection, data quality, and regulatory relevance rather than laboratory instruction.

The programme highlights how toxicological evaluation supports patient safety, referencing concepts such as PDEs, data availability, and efficient knowledge management within E&L programmes.

Yes, the course discusses assessment of data quality, analytical uncertainty, and effective oversight of CRO-generated E&L data to support confident regulatory submissions.

The training looks ahead to emerging trends, including standardisation efforts, improved collaboration, and the potential role of AI and modelling in E&L activities.

The live online format includes real-time discussions, case study-based learning, interactive workshops, and direct engagement with the trainer to support practical understanding.