Standardization and quality assurance hit the heights in China

11/05/2018

The National Institute of Metrology (NIM), China, the National Institute for Food and Drug Control (NIFDC) and the BIPM ran the 2nd International workshop on Protein and Peptide Therapeutics and Diagnostics (PPTD) on 10-12 October in Chengdu, China.

Organized also under the auspices of the Joint Committee for Traceability in Laboratory Medicine (JCTLM), the workshop has become a unique event in bringing together communities involved in standardization and quality assurance for protein and peptide analytes for both the diagnostic and therapeutic sectors.

The three day meeting brought together over 500 participants, with speakers from Academia, National Metrology Institutes, International Organizations, Pharmaceutical Companies, In Vitro diagnostic Companies, External Quality Assurance Scheme Organizers, Instrument Manufacturers, Reference Laboratories in Clinical Chemistry and the Pharmacopoeias.

The three sessions of the conference, notably, Drug Characterization and Quality Assurance, Research and Quality Control for in vitro diagnostics, and Reference Standards, Regulation and Metrology, attracted 87 oral presentations and over 30 posters. These provided a good overview of the relationship between research and development, manufacturing, regulation, written standards, measurement standards, and metrology, both and the national and global levels, and the future trends and interrelationships between these areas.

The workshop attracted strong support from the In vitro diagnostics sector and industry. There are currently 68 Reference Measurement Services listed in the JCTLM Database of Higher Order Reference Material, Methods and Measurements services from 7 Reference Measurement Laboratories in China.

Further information on the presentations can be found on the workshop website. (Link to http://pptd.ncrm.org.cn/)

The PPTD programme included three JCTLM presentations:

  • Developing Reference Measurement Procedures in Compliance with ISO 15193 by Anja Kessler (DE). Presentation available here
  • Developing CRMs for Diagnostics in Compliance with ISO 15194 by Karen Phinney (US). Presentation available here
  • Linking ISO 15195 accreditation with the performance of IFCC reference measurement procedures for enzymes by Mauro Panteghini (IT). Presentation available here

These three presentations may also be accessed from the Meetings section of this website.

 

 

 

Picture Caption: Opening of the PPTD-2018 workshop by Mr Yizhi Qin, the Deputy Director of the State Administration for Market Regulation, China.


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