|ESTP Committee for Scientific Standards
Mission: Scientific standards for scientific value
The Scope of the ESTP Committee for Scientific Standards (CSS, formerly the Guideline Committee) has a dual focus:
The internal focus is to update and inform the ESTP members about recent developments, changes and issues affecting guidelines and scientific standards which impact the daily work of toxicopathologists and correlated scientific fields. This should happen in an interactive fashion. Comments, proposals and criticism are welcome via email or in the Members Only area. The opinions and feed-back of the members will be a useful tool for the second focus:
The external focus of the CSS is the generation of comments or position papers related to guidelines and scientific standards which are then released by the ESTP Board and sent towards the regulatory bodies as input to these draft guidelines. The CSS may also review draft Points to Consider documents (eg from other Societies) which could have an impact on our work and thus ensure partnership with international STP Regulatory & Guideline committes. The process we follow is as follows:
- Individual members of the CSS are responsible for reviewing websites of specific regulatory bodies (namely EMA, FDA, ICH, OECD, EPA) and informing the Committee of any draft guidelines which fall within the scope of the CSS.
- The CSS will develop preliminary comments on behalf of the ESTP which are then submitted to the Society’s Executive Board for endorsement; the Board will make efforts to respond within 10 days. The CSS comments will be made available in parallel in the Members Only area and any member of ESTP is invited to make further comments or suggestions.
- If the Executive Board feel that the draft guideline could have a particularly significant impact on our work then a more proactive engagement of the Society’s membership may be proposed (including an extension of time available, if possible).
- The ESTP website will be updated with the final set of comments submitted to the regulatory body in question.
- Once the final guideline is published a statement to that effect (and a link) will be placed on the ESTP website.
The information available is placed under the categories shown below. Please note that most of the documents are available as PDF files.
If you would like to contact the members if the ESTP Committee for Scientific Standards, please click here.