Evaluation of extractables and leachables is a crucial step in the plan for product development. The interaction of pharmaceutical products with container closure systems, drug delivery devices, and bioprocess manufacturing systems is a major concern for regulatory agencies. Thus, it is important to thoroughly assess the migration of mobile molecules from the components and substances used in the manufacture and storage of drugs.
The event aims to bring together scientists, toxicologists, and E&L managers to discuss the most recent analytical strategies, regulatory updates, risk-based E&L programs, chemical characterization and toxicological risk assessment.
- Evaluation of extractables and leachables as a vital part in product development and launch
- Precise analytical techniques for E&L compound screening, identification and quantification
- Expert knowledge sharing in the planning, carrying out and reporting of E&L studies
- Analysis of regulatory revisions to maintain compliant and cost efficient regulatory approvals
- Industry standards for chemical characterization and toxicological risk assessment
- Comprehensive E&L evaluations of complex materials, products and processes