Gross and histopathology are very important aspects of preclinical research. They can be crucial endpoints for safety and toxicity studies. Oftentimes, they help determine whether adverse events were device related. Laboratory veterinarians that write preclinical veterinary reports rely on pathologists to help explain some in-life clinical observations. Regulatory guidance documents also require that preclinical protocols outline methods of assessment to include gross pathology and histopathology. Board certified veterinary pathologists are important contributing scientists for a GLP study.
Our next webinar discusses the important aspects of gross and histopathology for medical device preclinical studies, along with best practices to ensure that your study meets all the critical pathology requirements.
Join Marian Rippy, PhD., DVM., DACVP., Jessica Amilcar, DVM and Irena Brants, DVM for this 30 minute webinar on August 27 at 11:00 am.
About our speakers
Dr. Marian Rippy is President of Rippy Pathology Solutions and a medical device consulting pathologist. She provides pathology expertise for preclinical studies for medical device, pharmaceutical, and biotechnology clients to include guidance with protocols, model development, preclinical and histology laboratory selection, performing necropsies, interpreting light and electron microscopic pathology data and authoring pathology reports for use in regulatory submissions in the US and EU.
She is a highly experienced board certified veterinary pathologist with a PhD in Anatomic Pathology and is fluent in Good Laboratory Practice 21 CFR Part 58.
Dr. Jessica Amilcar is a Sr. Clinical Veterinarian. At GCMI she helps develop research protocols and various surgical models, writes expert veterinary reports, performs gross necropsy and interprets pathology reports, provides pre and post op veterinary clinical care, assists in the facility IACUC program, and oversees technical staff. She holds a veterinary degree from University of Florida.
Dr. Irena Brants is a study director and veterinarian. She brings years of experience in expert report writing in a variety of medical devices, ranging from EP, interventional cardiology, structural heart and many more. At GCMI she serves as a Program Director and delegate Test Facility Management.