Scientific and Regulatory Policy Committee

What Is the Scientific and Regulatory Policy Committee and What Does It Do?

The Scientific and Regulatory Policy Committee (SRPC) of the STP is tasked with providing scientific leadership on common or emerging global toxicologic pathology issues within the drug, chemical, and medical device industries in order to promote appropriate industry practices and good regulatory policies. Publications in Toxicologic Pathology, including recommendations for Best Practices, educational webinars, and responses to draft regulatory documents, are some of the common products of SRPC efforts. The SRPC is composed of both SRPC members and organizational liaisons. The liaisons provide connections to the STP Executive Committee (EC), Toxicologic Pathology journal of the STP, as well as various other groups including the ACVP, US FDA, Health Canada, NIH, ESTP, and the US EPA. New initiatives brought to the attention of the SRPC are discussed to determine if the topic should be deferred to a more appropriate committee, such as Regulatory Forum, or if additional SRPC action is needed, through either direct actions of the SRPC or through the formation of a formal Working Group Charter, both of which involve EC input and approval.

SRPC Working Groups include a lead, an SRPC Working Group liaison, and a mixture of other SRPC members and individuals from the general STP Membership. Additionally, there may be collaboration with or endorsement from other organizations such as the ASVCP, ACVP, BSTP, ESTP, JSTP, and ACT. When a ‘Points to Consider’ manuscript is produced, it is reviewed through the SRPC, the EC and other participating organizations prior to publication. A ‘Best Practices’ Manuscript would additionally include a process for full STP membership for review and comment prior to publication. SRPC members are selected with the intent of keeping a balance in the diversity of the membership (i.e., pharmaceutical, chemical, biotechnical, contract lab, academia, and government), limiting duplications in affiliations, and considering international colleagues where appropriate.

There are currently 13 SRPC Working Groups:

• Points to Consider for Clinical and Anatomic Pathologists in Conduct of Vaccine Studies
• The Pathologist’s Role in the 3Rs
• Identification of Potential Study Procedures that may confound interpretation of Pathology Data (also known as "block, batch, and plot effects")
• Expression of Severity for Clinical Pathology Changes in Safety Assessment Studies: Points-to-Consider
• Toxicity/Pathology Assessment for gene/cell therapies administered to target tissues
• Recommended Best Practices for Use of Informed (“Unblinded”) vs. Masked (“Blinded”) Histopathology Assessment in Nonclinical Studies
• Ad hoc Response to Regulatory Guidance on Pathology Peer Review
• Best Practices for Peer Review of Digital Images in GLP and Non-GLP Nonclinical Toxicology Studies
• Best Practices for Evaluation and Documentation of Sexual Maturity in Nonclinical Toxicity Studies
• Sectioning of non-rodent eyes for routine and ocular safety studies
• Points to Consider: Medical Device Implant Site Evaluation in Nonclinical Studies
• Survey - Points to Consider on Sample Retention Times
• Addressing Cause of Death in Nonrodent Toxicity - Best Practice

We welcome your ideas for new initiatives or any other comments that might facilitate our purpose of promoting sound and effective scientific and regulatory policy. Contact STP Headquarters.