This training program will offer insight into where extractables and leachables come from. Attendees will learn the regulatory expectations and trends for extractables and leachables in early phase development and learn which products may require E&L data in early phases. The program will also focus on how to design programs to meet the needs of early phase development - i.e. phase appropriate E&L programs.
Unanticipated regulatory scrutiny has caused several programs to be placed on clinical hold pending submission of E&L data, resulting in development delays and unplanned expense. This presentation will review regulatory trends, the nature of questions sponsors have been required to answer, and the types of programs encountering these issues. It will also provide guidance on how to design phase-appropriate E&L programs to address early phase expectations.
Why Should You Attend:
For many years, it has been more or less conventional wisdom that E&L data is a late-stage development concern, but current trends suggest this is changing. In recent months, the FDA has required multiple drug sponsors to provide detailed E&L packages and/or address specific questions in relation to E&L as early as Phase I. Questions have not only involved clinical trial container/closures systems, they also have signaled concern about equipment used in manufacturing of materials and devices used for dosing (i.e. infusion sets).Unanticipated regulatory scrutiny has caused several programs to be placed on clinical hold pending submission of E&L data, resulting in development delays and unplanned expense. This presentation will review regulatory trends, the nature of questions sponsors have been required to answer, and the types of programs encountering these issues. It will also provide guidance on how to design phase-appropriate E&L programs to address early phase expectations.
Learning Objectives:
- Understanding where extractables and leachables come from
- Learning the regulatory expectations and trends for extractables and leachables in early phase development
- Understanding which products may require E&L data in early phases
- How to design programs to meet the needs of early phase development - i.e. phase appropriate E&L programs
Areas Covered in the Webinar:
- Background and Overview of Extractables and Leachables
- What are extractables and leachables
- Where do they come from
- Why is there concern
Regulatory Requirements of Extractables and Leachables
- What is required for E&L
- Current Regulatory Trends - Early Phase Development
- What is being requested and why
- Review of what types of products are getting E&L requests - are there any trends
- Designing E&L studies to meet the unique needs of early phase development
Who Will Benefit:
- Drug Development Professionals
- CMC Analytical Chemists and Leads
- Manufacturing
- Quality Assurance
- Regulatory Affairs
- Program Management
- Clinical Leads
Course Provider
Wayland Rushing,
