To meet regulatory safety and quality standards, pharmaceutical manufacturers must demonstrate that any substances migrating from packaging materials into a drug remain below harmful levels during that product's development and shelf life. These extractables and leachables (E&L) can be found in many drug device combination products, from insulin pens to nicotine patches, with potential adverse impacts on the drug's safety, efficacy and stability. Understanding the varying regulatory demands for drug device combination products is essential to ensuring their successful development and testing.
This webinar offers expert insights into the regulatory and analytical challenges of E&L testing, addressing perspectives from both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA).
An understanding of key differences in E&L study designs between medical devices and pharmaceuticals will lay the foundation for examining how a product's primary mode of action (PMOA) should guide study design.
By using case studies and hosting a live Q&A session, presenters Dujuan Lu and Andreas Nixdorf will showcase how E&L testing aligned with recognized industry standards can deliver powerful evidence of safety, performance, compliance and due diligence.
Agenda
- Regulatory and analytical considerations in E&L testing of combination products – EMA perspective
- Regulatory and analytical considerations in E&L testing of combination products – US FDA perspective
- Case studies
- Q&A session
Who should attend?
This webinar will be of interest to project managers and stakeholders involved in the development of drug device combination products from Phase 1 to Phase 3, as well as anyone involved in chemistry, manufacturing and controls (CMC), formulation or regulatory affairs with an interest in combination products or E&L testing.
This webinar takes place on May 13, 2025, from 2:00 pm to 3:30 pm (GMT).
