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Webinar - On Demand

Illuminating Immunohistochemistry: Right-sizing your Validation and Regulatory Strategy

Date: October 3, 2024

Duration: 60 minutes

This session will explore in-depth the essential validation and regulatory strategies for IHC, providing crucial insights into the regulatory landscape and validation processes necessary for successful clinical trials.
 
Our expert speakers, Kennon Daniels, PhD, a scientific and regulatory in vitro diagnostic authority from Precision for Medicine, and Christie Bongel, MS, CT(ASCP), an experienced site director specializing in cytology and molecular diagnostics at Precision for Medicine, will guide you through the complexities of regulatory requirements, ensuring your IHC assays are compliant and optimized for clinical use. Topics include foundational laws and standards, aligning your validation and regulatory strategies with US clinical trial goals, and understanding regulatory differences between the US and Europe.

Topics covered:
  • Foundational overview of applicable laws and standards: Understand key regulations, including CLIA, CLSI, GCLP, and ISO, and their relevance to IHC.
  • Mapping your US regulatory path: Learn how to align your validation and regulatory strategy with your clinical trial goals in the US.
  • Navigating regulatory differences:
    Gain a high-level overview of the regulatory differences between the US and Europe, focusing on IHC in clinical trials.
  • Utilizing assays in clinical trials: explore how assays are used in clinical trials, including exploratory biomarkers and patient enrollment.

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Speakers

Kennon Daniels

Kennon Daniels, PhD
Precision for Medicine

Kennon Daniels, PhD, is a scientific and regulatory in vitro diagnostic authority, specializing in the development of US regulatory strategies and FDA marketing submissions for IVD assays and instruments. Her expertise spans all aspects of product development, analytical and clinical trial protocol designs, Q-Submissions, IDEs, de novos, 510(k)s, and pre-market approval platforms.

Christie Bongel_Square_260px

Christie Bongel
Precision for Medicine

Christie Bongel, MS, CT(ASCP), brings nearly two decades of experience in both research and clinical medicine. As the site director for Precision for Medicine’s IHC Center of Excellence in North Carolina, she excels in managing scientific operations and collaborating with clients. Christie is skilled in cytology, laboratory medicine, and molecular diagnostics. Christie earned her MS in Applied Biotechnology and is an ASCP certified cytotechnologist.