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.
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 (21 CFR 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: (1)summarizes the history & development of WSI (2) gives practical overview of the technology (hardware and software) (3) Current WSI status (4) describes digital workflows (5) Identifies common pitfalls (5) Best practices (6) Regulatory and validation considerations.
This webinar will instruct each participant on the current status of digital pathology WSI and explain its challenges in a nonclinical GLP-driven environment.
- 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
- 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:
- History of WSI
- The basics of operations
- Current terminologies – how Telepathology methods evolved into digital image data
- Brief overview on how a digital pathology platform works on a daily base.
- Which users should be involved at what time points.
- 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
- Successful example of current WSI applications in surgical pathology, in academia and in research.
- New developments in nonclinical research in order to respect the best practices.
- How a regulatory professional should be involved and
- How a quality assurance professional should contribute to the success of the digital pathology WSI platform.
- Live Q&A session
- Pharmaceuticals, Bio-technologies, Academia, Spin-Offs, Healthcare Institutions with R&D
- CEO, Boards, Managers, Scientists, PhD’s – related to R&D and Preclinical Research
- Regulatory VP, Regulatory Affairs professionals, Medical Writers
- 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
- MD’s working with animal models for human diseases
- Veterinary Pathologists interested in a career in Toxicological Pathology
- Clinical research associates who are interested in preclinical programs
- Key opinion leaders in Pathology working with laboratory
- Anyone involved with FDA
About the Presenter:
Dr. Elizabeth Neyens, DVM, DABT, Pathologist, is a board-certified toxicologist and pathologist and is graduated from the University of Utrecht in the Netherlands. 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 pre-clinical 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.
You will receive an email with login information and handouts (presentation slides) 1 day before the live webcast that you can print and share to all participants at your location.
Operating System: Windows any version preferably above Windows Vista & Mac any version above OS X 10.6
Internet Speed: Preferably above 1 MBPS
Headset: Any decent headset and microphone which can be used to talk and hear clearly
Can’t Listen Live?
No problem. You can get access to On-Demand webinar. Use it as a training tool at your convenience.
For more information you can reach out to below contact:
Toll-Free No: 1-302-444-0162
Email: [email protected]
You can also use the order form for making orders. Click here to download.