About the Virtual Seminar
Advances in computing power, whole slide scanners, and digital-based machine learning are helping pathologists “go digital” and optimize their workflow across teams and geographies. How does this approach apply for studies in need of a digital pathology peer review that is GLP-validated?
During this virtual event, we will join industry experts from Roche to describe a GLP-validated digital pathology workflow used for a candidate drug prior to human clinical testing. The technical controls needed to enable this validation were made possible by Deciphex, a leader in preclinical digital pathology software.
Following the presentation, key team members will participate in a live question and answer session with the audience about the qualification strategy for validating the system, focusing on the challenges and successes of the partnership that occurred along the way.
Simplifying Your Pathology Workflow
Digital Pathology Datasheet
Back to Basics: Utilizing Whole Slide Images for the Primary Evaluation and Peer Review of a GLP-Compliant Rodent Toxicology Study (SAGE Journals, 2021)
We are providing digital education options to keep you learning about topics you may be interested in. For more information, visit criver.com/digital-education.
Director, Safety Assessment IT Validation Quality Assurance, Charles River
Duane Miller directs activities for the Safety Assessment Quality Assurance organization related to audit and support of computer system validation. Mr. Miller has more than 15 years of experience in varying roles in quality assurance supporting GLP activities throughout his tenure with Charles River.
Quality Principal Specialist, Roche
Rémi Lavoisier provides operational quality support for GCP and GLP computerized systems delivery and maintenance, as well as maintaining the pRED Quality Management System. Mr. Lavoisier has over 11 years of experience in IT quality assurance, IT project management, and software development in regulated environments (GMP, GCP, GLP, Sox), leading and supporting implementation of IT solutions.
Director, Global Computer Systems Validation, Charles River
Alain Fraser plans, organizes, directs, and controls activities related to the operational application of Computer Systems Validation principles. Mr. Fraser has more than 25 years of experience in implementation of IT solutions in regulated environment (GLP, GMP, GCP). He has also participated in many continuous improvement projects (Lean Six Sigma) and uses this expertise in the implementation of computer and operational solutions within Charles River.
Lise Bertrand, DVM, MSc, DESV-Pathology, Diplomate ECVP
Senior Veterinary Pathologist, Charles River
Lise Bertrand leads and implements numerous digital pathology projects at our Lyon, France facility. She is a European Board-Certified Pathologist with over 10 years of experience evaluating nonclinical studies for the pharmaceutical and chemical industries.
Pierre Maliver, DVM, DiplECVP
Principal Scientist, Head of Clinical Pathology, Roche
Pierre Maliver leads the clinical pathology laboratory and co-leads the pathology department quality squad, which manages all quality aspects related to digital pathology. In addition, he manages preclinical safety pathology projects as part of the Roche Pharmaceutical Research and Early Development Organization (pRED). Mr. Maliver is a Board-Certified Veterinary Pathologist from the European College of Veterinary Pathologists (ECVP).