Digital Pathology: Introduction to Quality & Compliance

Product Id : HE96
Instructor : Dr. Elizabeth Neyens
Dec 13, 2018 1:00 PM ET | 12:00 PM CT | 10:00 AM PT | 90 Minutes

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Overview

Digital pathology has been widely discussed since several years in Societies of Surgical Pathologists. Recently, it’s use has been widely increased in additional fields such as in Academia for educational purposes, but also in Non-Clinical drug development research. In 2017, the FDA approved the first Whole Slide Imaging System (WSI) for digital pathology that allows the interpretation of digital surgical pathology slides prepared from biopsied tissue. Its non-binding guidance details the technical performance assessment of digital pathology of WSI devices. Today, accreditation agencies are still working to establish comprehensive policies that ensure proper validation towards a global use.

This webinar will instruct each participant on the current status of digital pathology WSI and explain its challenges in a nonclinical GLP-driven environment.

Why Should You Attend:

The validation of digital pathology systems in the regulated nonclinical environments remains challenging for many R&D facilities due to lack of knowledge, but also due to inefficient multidisciplinary interactions. The society of Toxicological Pathologists (STP) published a few position papers on the compliance of Pathology Image Data (21Cfr Parts 58 and 11) and its current applications, but many topics in relation to WSI are not yet published. Prospective users need to acquire digital knowledge, but also new skills in order to identify best paths of success. Intra-institutional and inter-institutional collaborations are entering an exciting discipline with far-reaching beneficial effects.

This webinar will guide you efficiently toward the paths of success:

  • Summarizes the history & development of WSI
  • Gives practical overview of the technology (hardware and software)
  • Current WSI status
  • Describes digital workflows
  • Identifies common pitfalls
  • Best practices
  • Regulatory and validation considerations

It will explain you how to select the basic technologies, how to verify and validate current hardware/software applications, how to implement efficiently new workflows with best practices, and how to overcome challenges.

After having attended this webinar you should be comfortable to interact with vendors, with researchers, histologists and pathologists. You should be able to understand the crucial role of the QA department. Overall, your skills will be adjusted in order to react promptly and efficiently to multidisciplinary professionals in digital pathology.

Areas Covered in the Session:

  • It will begin with the history of WSI, and the basics of operations – current terminologies - how telepathology methods evolved into digital image data
  • This will be followed by a brief overview on how a digital pathology platform works on a daily base. Which users should be involved at what time points. How the toxicological pathologist should use the WSI during the course of a study, how digital data are collected & recorded, how to conduct peer-reviews, if applicable
  • The third part section of the webinar will show you a successful example of current WSI applications in surgical pathology, in academia and in research. It will highlight the new developments in nonclinical research in order to respect the best practices.
  • The final section of this webinar will give you insights how a regulatory professional should be involved and how a quality assurance professional should contribute to the success of the digital pathology WSI platform.
  • Questions will be answered during the final session.

Who Will Benefit:

  • CEO, Boards, Managers, Scientists, PhD’s – related to R&D and Preclinical Research
  • Regulatory VP, Regulatory Affairs professionals, Medical Writers
  • Quality VPs, Quality Managers, Quality Engineers
  • IT VPs, Software companies related to Digital Imaging 
  • GLP professionals, Histology professionals, laboratory animal professionals
  • Technicians related to laboratory animals 
  • PhD, Post-Docs, Students in Veterinary Pathology
  • Professors, Associate professors of Veterinary medicine colleges, Pathology departments
  • Clinical research associates who are interested in preclinical programs
  • Key opinion leaders in Pathology working with laboratory animals
  • Pharmaceuticals, Biotechnologies, Academia, Spin-Offs, Healthcare Institutions with R&D
Speaker Profile:

Dr. Elizabeth Neyens is graduated from the University of Utrecht in the Netherlands as DVM, & Veterinary Pathologist. During her European residency she was rewarded twice for her research in Oncology and was recognized as best Junior lecturer in Pathobiology. She started her career as a Toxicological Pathologist in Charles River Preclinical Services and continued as Preclinical Head of the Pathology department in Baxter, Austria. A few years later, she decided to return back to Canada in order study for her Boards in Toxicology while assuming different roles as Senior Pathologist in various CRO’s and. She passed successful the American Board in Toxicologist in 2015 and accepted the role of Scientific Advisor for leading CRO in Israel. She specialized in preclinical evaluations/interpretations of small & large molecules, medical devices, ocular diseases and carcinogenicity studies; has broad experience with Drug development of Biologics, Quality Audits, & Regulatory discussions.

Recently, she decided to build her own Consultancy Firm in Europe with offices in Flanders, Belgium and Vancouver, Canada in order to support her international clients with excellence.


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