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, and can have an adverse impact on the drug’s efficacy, safety and stability. Understanding the varying regulatory demands for drug device combination products is essential to the success of their development and testing.
This webinar offers expert insights into the regulatory and analytical considerations of E&L testing, covering terminologies and definitions from both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA).
An understanding of the key differences in E&L study designs between medical devices and pharmaceuticals will lay the foundation for an examination of how a product’s primary mode of action (PMOA) should guide study design.
Using case studies and a Q&A session, presenters Dujuan Lu and Andreas Nixdorf will also show how E&L testing to recognized industry standards provides 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, Phase 1 to Phase 3 stakeholders and anyone involved in chemistry, manufacturing and controls (CMC), formulation or regulatory affairs with an interest in either combination products or E&L testing.
This webinar takes place on May 13, 2025, from 2:00 pm to 3:30 pm (GMT).
