Webinar

The Impact of ICH E6(R3) on Biospecimen Management

Tuesday, April 15
11:00am ET
Reserve your spot

The transition from ICH E6(R2) to ICH E6(R3) marks a pivotal shift in regulatory expectations for biospecimen management in clinical research. With an expanded emphasis on risk-based quality management, enhanced data governance requirements, and increased sponsor oversight responsibilities, organizations must evolve their internal processes to maintain compliance.

Join us for an insightful webinar featuring distinguished experts, including Edye Edens, Rust Felix, and Aman Khera. Together, they will delve into how ICH E6(R3) will redefine biospecimen management practices. Don't miss this opportunity to prepare for the future of clinical research.

Attendees will:

  • Gain a clear understanding of the ICH E6(R3) language that directly impacts biospecimen operations.
  • Learn how to proactively align biospecimen management practices with the new regulatory framework.
  • Discover how to assess compliance ahead of the EMA's July implementation deadline.
Edye Edens
Life Sciences Legal & Regulatory Expert, Kulkarni Law Firm
Rust Felix
CEO & Co-founder, Slope
Aman Khera
Regulatory Science & Innovation Advisor; President, TOPRA
Biospecimen lifecycle software, data, and services for complex clinical trials.
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