ELSIE's Current Program and Organization
ELSIE is comprised of pharmaceutical, biotechnology, and medical device companies who advance the understanding of the impact of extractables and leachables on patient safety, product quality and process performance. ELSIE provides opportunities to share and leverage experiences, insights, and practices with respect to the potential safety impact of drug product packaging, delivery and manufacturing systems by supporting and publishing research, and participating in the global scientific and regulatory communities.
Board of Directors
ELSIE is managed by a Board of Directors. The Board is comprised of two representatives from each member company and operates under bylaws approved by the Board.
The Safety Information Working Group is comprised of toxicologists who progress the population of the database, address questions on current safety reports, explore new opportunities or approaches for reports, and develop strategic initiatives related to risk assessments for extractables and leachables.
Consisting mostly of chemists, the Materials Information Working Group is working with dedicated researchers to collect materials information for the population of the Knowledge Base. The team conducts benchmarking and analysis of key E&L related topics and is working to establish a mechanism for sharing material data among ELSIE members.
Knowledge Management Working Group
The Knowledge Management Working Group is leading ELSIE’s development of a second phase database (the “Knowledge Base”) that will include both safety and materials information in a relational/linked platform.
ELSIE Forums provide a unique opportunity for industry members to initiate discussions regarding E&L related challenges while gaining access to ELSIE members under the umbrella of the consortium.
The Pharmaceutical Group at Drinker Biddle & Reath, LLP provides ELSIE with scientific, legal and administrative support. The expense of this effort is shared equally, on a pro rata basis, by each member company of the consortium, pursuant to a budget agreed by the Board.