ELSIE MEMBERS
 
AbbVie
Amgen
AstraZeneca
Baxter
Biogen Idec
Boehringer Ingelheim
Eli Lilly
arrow Fresenius Kabi
GlaxoSmithKline
Merck
Merck Serono
Novartis
Pfizer
sanofi
Teva

 

 

Welcome To ELSIE

The Extractables and Leachables Safety Information Exchange (ELSIE) was formed in 2007. ELSIE’s core objective is to establish a comprehensive database that provides a jointly-developed and credible source of (i) Safety information on extractables and leachables and (ii) Extraction profiles and standardized study protocols for a range of materials commonly used in pharmaceutical, biological and device applications and processes (e.g., container closure systems, devices, manufacturing/processing)

The ELSIE Database

  • Advances principles of Quality by Design by enhancing the prospects for identifying potential safety issues at the initial stages of the development process, when container-closure materials are being screened and selected.
  • Supports member companies’ regulatory filings
  • Reduces duplication of effort and minimize testing.
  • Decreases the risk of substantial, unanticipated delays and associated costs.

REQUEST FOR PROPOSALS: NEXT GENERATION ELSIE KNOWLEDGE MANAGEMENT DATABASE

The Extractables and Leachables Safety Information Exchange (ELSIE) has, as a core objective, to establish a comprehensive database that provides a jointly-developed and credible source of (i) Safety information on extractables and leachables and (ii) Extraction profiles and standardized study protocols for a range of materials commonly used in pharmaceutical, biological and device applications and processes (e.g., container closure systems, devices, manufacturing/processing). ELSIE currently has in place a database of safety information on extractables and leachables, and is now seeking proposals for the creation of a Next Generation ELSIE database (the ELSIE “Knowledge Base”). To this end, ELSIE has developed an RFP for development of this Knowledge Base. The RFP provides a description of the project and the evaluation criteria. The proposal process will be completed in three phases in order to best evaluate a vendor’s ability to provide the Knowledge Base and understand the needs and use of the Knowledge Base by ELSIE members. This RFP represents the first phase of the ELSIE RFP process, requesting proof of concept. In the second phase a selected number of vendors will be asked to develop a prototype system. The third phase will include further refining of the prototype to deliver the first release version. Please contact the ELSIE Secretariat at ELSIEREPLY@dbr.com if you would like a copy of the RFP

Vendor Webinar Q&A

 

 

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