PRLog (Press Release)
- Feb. 28, 2012 -
Extractables and leachables are becoming an ever increasing area of regulatory scrutiny, which can be attributed to a number of product recalls associated with leachables. Greater knowledge, understanding and awareness over the years has resulted in this focus expanding from OINDPs (Orally Inhaled and Nasal Drug Products) to multiple drug product types, as well as to medical devices. Regulatory bodies and working groups continually drive the needs for harmonized approaches, ever-evolving best practices and improved guidance and recommendations in this area.
Coming to Baltimore, MD on 15-17 May 2012, Extractables and Leachables USA 2012 is a launch event for organizers Pira International and Smithers Rapra following their successful European E&L conferences, and will provide a unique forum for delegates to come together to discuss all of the current E&L issues facing the pharmaceutical industry. Key areas being covered by the conference include presentations by industry experts, toxicologists and regulators, on the latest regulatory perspectives, best practices, activities of industry working groups PQRI, IPAC-RS and ELSIE, as well as a number of individual case studies.
A particular highlight of the programme will be a focus on the toxicologist’
s perspective by William Beierschmitt, Regulatory Strategy Lead, Drug Safety Research & Development at Pfizer, in which he will explain the importance of E&L’s to the toxicologist and demonstrate the role of toxicologists in assessing the safety of chemicals. The agenda will also delve into a discussion of the Chemical Assessment Triad and its application to packaging systems safety assessments, in particular exploring how the Triad can be used to address when a safety assessment is complete, presented by Dennis Jenke, Baxter Distinguished Scientist at Baxter Healthcare.
The Extractables and Leachables USA conference will be co-located with Pira’s successfully established Global Food Contact event, which will provide delegates with unrivalled networking opportunities across the food and pharmaceutical packaging supply chains. See www.eandl-conference.com for more information on this E&L event.