The Impact of ICH E6(R3) on Biospecimen Management
Webinar Date/Time: This event is available on demand
With the EMA adopting ICH E6(R3) in July, sponsors with EU trial operations must now meet stricter regulations that directly impact sample management; this demands tighter data governance, risk-based approaches, and increased sponsor oversight to stay compliant
Register Free: https://www.appliedclinicaltrialsonline.com/act_w/biospecimen-management
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.
This insightful on-demand webinar—featuring regulatory experts Edye Edens and Aman Khera, and Slope CEO and Cofounder Rust Felix—explores how ICH E6(R3) will redefine biospecimen management practices. Don't miss this opportunity to prepare for the future of clinical research.
Key Learning Objectives
- Understand which ICH E6(R3) language directly impacts biospecimen operations.
- Learn how to align biospecimen management practices with the new regulations.
- Discover how to assess your risk profile compliance ahead of the EMA's implementation deadline.
Who Should Attend
- Clinical operations, trial operations, clinical development, clinical program lead/leadership, clinical trial management, clinical study manager
- Lab vendor management, lab ops
- Clinical data management
- Translational research, translational medicine, translational sciences
- Biomarker, biospecimen operations, bioanalytical sciences, biosample operations
- Clinical Quality, Clinical QA, Clinical compliance, Clinical oversight, Clinical Risk
Speakers:
Rust Felix is the CEO and cofounder of Slope, a company dedicated to empowering clinical trial stakeholders to ensure protocol adherence and regulatory compliance by providing full visibility and a traceable chain of custody throughout the sample journey. Felix's leadership has been instrumental in Slope's growth and innovation, focusing on reducing site burden, enhancing data quality, minimizing risk, and accelerating study timelines.
Edye Edens
Life Sciences Legal & Regulatory Expert
Kulkarni Law Firm
Edye Edens is a seasoned legal and compliance professional specializing in clinical research and life sciences. With a juris doctor from Indiana University and a master’s in international research ethics, she brings over 15 years of experience in research compliance, regulatory operations, and clinical trial oversight. She currently acts as senior attorney for the Kulkarni Law Firm, where she advises AMCs, sponsors, CROs, and research sites.
Aman Khera
Regulatory Science & Innovation Advisor; President
TOPRA
Aman Khera, the "rebel regulator," has nearly 3 decades of experience in life sciences clinical research. Known for her pragmatic, patient-first approach, she advises biotech and pharma companies, challenging conventional regulatory and clinical development norms. Khera has led regulatory strategy and development services for various client pharma/biotech companies, guiding organizations from early agency engagement to commercialization.
Register Free: https://www.appliedclinicaltrialsonline.com/act_w/biospecimen-management
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