The role of the Toxicological Pathologist in Preclinical Drug Development according to 21 Cfr. Part 11/58

01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar

"Hear from Dr. Elizabeth Neyens, she is graduated from the University of Utrecht in the Netherlands as DVM, & Veterinary Pathologist. "

React promptly and efficiently to pathologists

Description

Preclinical R&D programs incl. adequate IND submission represent a regulatory-driven prerequisite before authorizing the administration of a new drug or implantation of a new medical device into human volunteers.

The role of the Toxicological Pathologist is to act as a preclinical expert. He/She diagnoses, interprets, and deliver written statements on any organ/tissue changes related directly or indirectly to the administration of the new drug. The final pathology report represents the end-result of the in-vivo experiments and will be incorporated into the IND submission.

Why should you attend

Preclinical testing is often conducted in CRO’s, but also Pharmaceutical companies, Biotech’s or Academia are able to conduct fully or partially Toxicological Programs. Yet although there are FDA guidance’s on how to conduct a preclinical program, often the research teams outsource their preclinical projects due to lack of knowledge about Pathology, Toxicology, or QA. Consequently, there is a substantial risk that sponsors are unable to track the progression, how to react to adverse events or conduct official peer-reviews. Worse, this often leads to confusion, delays results, or gives irrelevant conclusions in pathology reports. The draft pathology report(s) precedes the final report which will be an integral part of the IND submission.

This webinar will explain you (1) the strategic role of the toxicological pathologist according to 21 Cfr. Part 11/58 (2) it will show you how to insure proactivity during the whole course of your preclinical program and (3) will give you communication tools in order to collaborate efficiently with your most valued expert.

Areas Covered

This webinar will instruct the participant on the strategic role & responsibility of the toxicological pathologist in a preclinical GLP-driven environment. It will explain you how to track progress, how to deal with unforeseen circumstances, and how to communicate efficiently till the final signed pathology report. You will be able to get better understanding of the complex terminologies in pathology (SEND, audit trail, NOAEL/MABEL, HCD), the different stages of pathology reports (draft vs. final) incl. tabulation and peer-reviews in a way that it will ensure compliance, consistency, and reproducibility. After having attended this seminar you should be able to react promptly and efficiently to pathologists, but also to regulators related to pathology questions.

•            It will begin with a strategic view of the toxicological pathologist and how he/she can help you to streamline               your R&D program in addition to ensuring regulatory compliance.
•           This will be followed by in depth explanation on how a toxicological pathologist should act during the                           course of the study, how data are collected & recorded, how to conduct peer-reviews, how to update                            pathology reports while ensuring data integrity, compliance and best practices.
•            The third part section of the webinar will show you a few special circumstances and will introduce new                        approaches related to digital pathology: how to ensure compliance with artificial intelligence.
•            The final section of this webinar will give you insights how to react towards regulatory questions related to                   pathology.

Who will Benefit

•              Pharmaceuticals, Biotechnologies, 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
•              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
•              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 animals

Industries who can attend

This 90-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel


Speaker Profile

Dr. Elizabeth Neyen

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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