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

Improvement of Knowledge Improving Quality = Improvement of Knowledge

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

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

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

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.

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!

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)

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

Requirements TDI-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

Future work TDI-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 WHO initiative update of standardised formats for case data and definitions of data elements (contributions of L. Onyon and J. Tempowski, this meeting)

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?

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? Punkte, die bei diskutiert werden sollen

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