Inhaler
Extractable and leachable testing of materials from which drug delivery devices like these are made are crucial for manufacturers to meet regulatory requirements under the United States Pharmacopaeia (USP).The three-day event, to be held on May 7-9, 2013, in Providence, Rhode Island, will feature a pre-conference workshop, poster sessions and a two-day speaker programme covering case studies on materials composition and quality, toxicological perspectives on E&Ls and challenges in E&L studies.
Smithers Rapra’s annual Extractables and Leachables conferences attract a wide range of delegates. E&L USA 2012 was attended by an expanse of companies from pharmaceutical manufacturers, medical device manufacturers, packaging and materials suppliers to CROs, government and academia. Last year over 65 delegates visited the conference.
E&L USA 2013 will cover the latest developments from industry practitioners and working groups to meet regulatory requirements and ensure compatibility in drug-package combinations. Speakers lined up include Dennis Jenke, Baxter Healthcare; Bill Beierschmitt, Pfizer, and Diane Paskiet, West Pharmaceutical Services.
Dan Norwood, Distinguished Research Fellow, Boehringer Ingelheim Pharmaceuticals, is one of the keynote speakers for E&L USA and scheduled to discuss the United States Pharmacopeia and the issue of leachables and extractables: past, present and future. On current challenges with respect to E&Ls, Norwood commented: “the most significant current challenge for the entire pharmaceutical landscape is reaching consensus among all of the various stakeholders regarding how to address the key issues related to E&Ls for all drug product types and medical devices.”
Further highlights of the conference include case studies from Johnson & Johnson, EMD Millipore and BD Medical on biodegradable and permanent implantable devices, single-use systems and elastomeric components for parenteral packaging. Plus the pre-conference workshop, led by Dr Andrew Feilden, Chemistry Operations Director and Sukhy Toot, Product Manager - Medical Devices at Smithers Rapra, will cover an introduction to extractables and leachables, material selection, risk based analysis and extractable and leachable testing. And, new for 2013, poster sessions will allow attendees to hear even more about recent research and findings relating to all areas of E&Ls.
For more information on the conference visit www.eandl-conference.com.