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Gerhard Heinemeyer Herbert Desel Joanna Tempowski

Toxicological Documentation & Information Network A European Challenge? Results from a Workshop, September 2002, Berlin. Gerhard Heinemeyer Herbert Desel Joanna Tempowski. Improving Quality. =. Improvement of Knowledge. What is TDI? Toxicological Documentation and Information.

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Gerhard Heinemeyer Herbert Desel Joanna Tempowski

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  1. Toxicological Documentation & Information NetworkA European Challenge?Results from a Workshop, September 2002, Berlin Gerhard Heinemeyer Herbert Desel Joanna Tempowski

  2. Improving Quality = Improvement of Knowledge

  3. What is TDI?Toxicological Documentation and Information • Project of research and development • Participants: • 7 German poison centres (active, developers) • 3 Poison centres (passive, received software etc.) • BfR*) (scientific consultant, development) • Objective: To develop standard software tools for exchange of data from industry to poison centres and BgVV/BfR • Products, substances, cases • Running since 1999 *) Federal Institute for Risk Assessment, former BgVV

  4. Project TDI (I) • Aim:To improve knowledge about product composition by electronic exchange of formulation data between industry, authorities and poison centres in Germany • Approach:To install a common structure for data exchange between industry, poison centres, and national authorities

  5. TDI (II) - Results • Implementation of a standardised data exchange format • Databank TDI • Aggreement upon standard procedures • Extension to XML-format • European Impact? • for centres and agencies • for industry

  6. Presentation of results (TDI-Workshop Sept. 2002) • To inform about TDI and present results • To discuss results and possible consequences • To give an overview on the current situation in Europe • To discuss the impact of collaboration with industry and among poison centres on an international basis.

  7. Questions?TDI-workshop • Are there similar approaches elsewhere? • Can experiences from this study be transferred to Europe? • What is the role of EU, EAPCCT and others (WHO)? • Round table was held to discuss benefits and possible problems!

  8. Results from Round Table (I) TDI-workshop • Increase knowledge on frequency and severity of poisoning • Interested parties for this exchange may be represented by: • Poison centres (can more readily share information about cases) • Industry (is informed about safety of products) • Regulators (data to support priority setting for chemical evaluations and better information about toxic effects in humans)

  9. Results from Round Table (II) TDI-workshop • Distribution of product information on the basis of accepted standards (standardised formats and standardised protocols) • Same level of information for all PC's • Product information will be more readily accessible, particularly where products are marketed in several countries (Industry doesn't want to have multiple partners) • Linkage of product and case documentation • Improvement of risk assessment approaches

  10. RequirementsTDI-Workshop • Intention • Each partner (poison centres, industry, regulators, and others) must have the intention and commitment to become involved in a system of data exchange • Standardised formats • Agreement for the data elements to be exchanged • Use of the XML language should be given reference

  11. Future workTDI-workshop • start co-operation • this minisymposium • Establish an electronic discussion forum • www.tdi-network.org • Standardize terms (e.g. substances) • BfR provides a list of substances terms and synonyms • EAPCCT initiative for improvement of product information exchange • this minisymposium • WHO initiative • update of standardised formats for case data and definitions of data elements (contributions of L. Onyon and J. Tempowski, this meeting)

  12. This mini-symposium? EAPCCT initiative • discuss the impact of using standard data by electronic exchange • specific opinions regarding the role of the EAPCCT? • Focus on product information and their electronic dissimination • Approvement by EAPCCT and publication? • other objectives, recommendations?

  13. Aims, objectives to be discussed today? • Do PC‘s see similar benefits? • Prerequesites • Recommendations? • Standardised data exchange format for European industry, poison centres and agencies • Should EAPCCT have a lead function as proposed by the workshop and which are the consequences?

  14. This minisysmposium: • four lecturs about data exchange • 45 minute discussion • recommendations how to proceed?

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