| |
|
|
|
Xtalks, Online
2025-05-14
Drug-device combination products offer patients and healthcare providers convenient access to safe and effective treatments.
However, integrating drugs and devices into a single product introduces unique challenges—particularly in ensuring patient safety through rigorous evaluation of extractables and leachables (E&L). One of the most complex aspects of E&L testing for combination products is aligning the often differing regulatory expectations from both drug and device health authorities.
This webinar will explore the contrasting standards for chemical characterization and toxicological qualification of E&L substances and propose a unified, dual-purpose strategy that satisfies both perspectives.
By integrating ISO 10993-12/-18 and USP <1663>/<1664> for chemical assessment, along with ISO 10993-17 and ICH/PQRI-based frameworks for toxicological qualification, attendees will gain practical guidance on developing a compliant and comprehensive E&L program for combination products. In this webinar, the expert speakers will focus on the following topics:
Best practices for E&L testing in drug-device combination products
Approaches to toxicological qualification of leachables using regulatory-aligned methodologies
How to effectively apply both ISO 10993 and USP <1663>/<1664> standards in a unified E&L strategy
Regulatory considerations for navigating drug and device requirements in combination product development
Register for this webinar today to gain insights into developing a compliant, dual-purpose extractables and leachables program for drug-device combination products.
Keywords: Medical Device, Drug Development, Healthcare, CRO, Patient Safety, Drug Manufacturing, Regulatory, Regulatory Compliance, Combination Product, Extractables & Leachables
|
|
|
|
|
|
|
|
Organized by:
|
|
Xtalks |
|
|
Invited Speakers:
|
|
Eric Hill, Chief Scientific Officer, Chemistry and Extractables & Leachables Labs, BA Sciences
Dr. Isaac Mohar, Principal Scientist/Toxicologist Gradient
|
|
|
|
|
|
|
|
Deadline for Abstracts:
|
|
2025-05-14
|
|
|
|
|
|
|
|
Registration:
|
|
Free Registration
|
|
|
E-mail:
|
|
tristan@xtalks.com
|
|
|
|
|
|
|
|
|
|
|
|
|