ASVCP Regulatory Affairs Committee
The Regulatory Affair Committee (RAC) of the ASVCP strives to advance toxicologic clinical pathology in industry by educating, promoting communication and publishing contemporary best practices for clinical pathology in industry. Primary RAC activities include sponsorship of resident externships in industry, development and publication of guidelines for veterinary clinical pathology aspects in industry, and fostering of collaboration with ACVP and STP to improve harmonization efforts. The RAC also surveys government regulatory agencies, national and international committees, the pharmaceutical industry, professional organizations, and oral and written communication for current and impending legislation/regulations or publications that may affect the daily business of our membership. The RAC forms consensus opinions and responds appropriately to these agencies on behalf of the ASVCP. Many of our members are employed in the industry (contract research organizations, biotech, pharmaceutical, agrochemical and food industries, and private diagnostic laboratories).
2019-2020 Regulatory Affairs Committee:
Chair: Tara Arndt, firstname.lastname@example.org
Amy Warren, EB Liaison
Tara Arndt, email@example.com
Eric Schultze, SRPC liaison
William Siska, firstname.lastname@example.org
Laura Cregar, Laura.Cregar@mpiresearch.com
Niraj Tripathi, Niraj.Tripathi@covance.com
Eric Fish, email@example.com
Michael Logan, firstname.lastname@example.org
Yemi Adedeji, Adedeji.email@example.com
Tara Arndt, firstname.lastname@example.org
Kate Biddle, Kathleen.Biddle@pfizer.com
Clinical Pathology Resident Externships in Industry (2020 TBD)
Black LJ, et al. Veterinary clinical pathology trainees benefit from toxicologic externship opportunities in the biopharmaceutical industry. Vet Clin Path 2016:5-6.
Adedeji AO and Huang C-T. Toxicologic and comparative clinical pathology externship scholarships broaden clinical pathology resident training opportunities. Vet Clin Path 2015:1-2.
RAC Endorsed Publications:
Ramaiah L, et al. Principles for assessing adversity in toxicologic clinical pathology. Toxicol Pathol 2017:260-266.
Tomlinson L, et al. STP best practices for evaluating clinical pathology in pharmaceutical recovery studies. Toxicol Pathol 2016:163-72.
Poitout-Belissent F, et al. Reducing blood volume requirements for clinical pathology testing in toxicologic studies—points to consider. Vet Clin Path 2016:534-51.
Tomlinson L, et al. Best practices for veterinary toxicologic clinical pathology, with emphasis on the pharmaceutical and biotechnology industries. Vet Clin Path 2013:252-69.
Young JK, et al. Best practices for clinical pathology testing in carcinogenicity studies. Toxicol Pathol 2011:429-34.
Reagan WJ, et al. Best practices for evaluation of bone marrow in nonclinical toxicity studies. Vet Clin Path 2011:119-34.
Also Toxicol Pathol 2011:435-48.
Morton D, et al. Best practices for reporting pathology interpretations within GLP toxicology studies. Toxicol Pathol. 2006:806-9.
Boone L, et al. Selection and interpretation of clinical pathology indicators of hepatic injury in preclinical studies. Vet Clin Path 2005:182-8.
Aulbach A, et al. Influence of study design variables on clinical pathology data. Toxicol Pathol 2017:288-295.
Reagan WJ. The American Society for Veterinary Clinical Pathology Regulatory Affairs Committee’s clinical pathology best practices recommendations will impact the discipline of veterinary toxicologic clinical pathology. Vet Clin Path 2013:247-9.
Burkhardt JE, et al. Recommendations for the evaluation of pathology data in nonclinical safety biomarker qualification studies. Tox Pathol 2011:1129-37.
Schultze AE et al, Veterinary clinical pathologists in the biopharmaceutical industry. Vet Clin Path 2008:146-58.
Drug Development Presentation: Introduction to Toxicologic Pathology
Links of Interest: Related Society Links
Society of Toxicologic Pathology
European Society of Veterinary Clinical Pathology
International Society for Animal Clinical Pathology
Division of Animal Clinical Chemistry, AACC
European Society of Toxicologic Pathology
British Society of Toxicologic Pathology
Society of Toxicologic Pathology-India
Latin American Society of Toxicologic Pathology
Japanese Society of Toxicologic Pathology
French Society of Toxicologic Pathology