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Home > Nanotechnology Columns > Bergeson & Campbell, P.C. > Global Summit on Regulatory Science Will Focus on Nanotechnology Standards and Applications

Lynn L. Bergeson
Managing Director
Bergeson & Campbell, P.C.

Abstract:
The 2016 Global Summit on Regulatory Science (GSRS) was held September 7-9, 2016, in Bethesda, Maryland.

September 7th, 2016

Global Summit on Regulatory Science Will Focus on Nanotechnology Standards and Applications

The 2016 Global Summit on Regulatory Science (GSRS) was held September 7-9, 2016, in Bethesda, Maryland. See http://www.fda.gov/AboutFDA/CentersOffices/OC/OfficeofScientificandMedicalPrograms/NCTR/WhatWeDo/ucm488022.htm Each GSRS meeting focuses on an area of regulatory science that would benefit from discussions aimed at identifying future research directions, and this GSRS meeting will focus on nanotechnology standards and applications, building on an October 11, 2015, GSRS workshop. The 2015 workshop focused on physico-chemical measurements and standards relevant to nanomaterials in the "pristine state" and in complex matrices. This meeting will expand on that focus to include both physico-chemical and biological measurements and standards for specific applications, namely nanomaterial-containing drugs, medical devices, food and food contact materials, and personal care products. The goals of the meeting are to:

- Educate a broad group of stakeholders on the state of the art in nanotechnology science, measurement methods, and standards for regulatory applications;
- Identify the most immediate needs in nanotechnology science, measurement methods, and standards relevant to regulatory applications; and
- Facilitate greater coordination between stakeholders in the development of standards.

The desired outcomes of the meeting include:

- Publication of a meeting report: Information generated by the brainstorming panel sessions will be summarized to capture and prioritize needs for new consensus-based documentary standards, guidance documents, and reference materials specifically targeted for regulatory applications of nanotechnology products. Similarly, state-of-the-art and existing gaps in nanotechnology regulatory science will be addressed across a broad spectrum of applications. This information will be incorporated in a publicly available report; and
- Global consensus for a centralized website: There are a number of websites that contain information on standards, for example, the Nanotechnology Standards Database hosted by the American National Standards Institute. A new, centralized website containing links to existing lists of international standards is needed to consolidate the information in a single location. It could be examined whether this website can be part of the European Union's Nanomaterials Observatory to be established and hosted by the European Chemicals Agency.

The read-ahead material is a 26-page document listing U.S. and international regulatory agency guidance documents, documents from other organizations, documentary standards, publicly available protocols, and nanoscale reference materials. See http://www.fda.gov/downloads/AboutFDA/CentersOffices/OC/OfficeofScientificandMedicalPrograms/NCTR/WhatWeDo/UCM519158.pdf

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