Falmouth, Maine February 18, 2014:
Smithers Rapra's Extractables and Leachables USA 2014 (E&L USA) has released their full agenda with presentations from MedImmune, Intertek, VR Analytical, Novo Nordisk, Toxikon, Baxter, IPAC-RS and more. The three day event will feature a pre-conference workshop, poster sessions and a two day speaker program covering case studies on E&L in single-use systems, implantables and medical devices, approaches for designing extraction studies and challenges in risk management strategies.
Smithers Rapra's annual Extractables and Leachables conference attracts a wide range of delegates including Compliance Managers, Regulatory Affairs Managers, R&D Directors, Product Safety Managers, Technical Engineers, Market Development Directors and Packaging Specialists from a broad expanse of companies; from pharmaceutical manufacturers, medical device manufacturers, packaging and materials suppliers to CROs, government and academia.
Extractables and Leachables USA 2014 covers the latest developments from industry practitioners to working groups discussing how to meet regulatory requirements and ensure compatibility in drug-package combinations. Speakers presenting this May include: Dr. Gyorgy Vas from Intertek, Desmond Hunt from United State Pharmacopeia and Dr. Ingrid Markovic who works for the Center for Biologics Evaluation and Research for Food and Drug Administration.
Dr. Jim Castner of Pharma Interface Analysis is one of this year's speakers presenting new findings from a chemometric approach for developing strategies for screening of extractables from polymeric materials. Dr. Castner comments that this chemometric approach can "provide a more systematic strategy in conducting these investigations across multiple applications, which can then lead to improved risk assessments for extractables from multiple contact surface vectors."
Dr Castner's presentation is complemented by a session with Dr. Daniel Norwood of Boehringer Ingelheim taking attendees through the intellectual process of designing an extraction study. Dr. Norwood comments that there are many considerations for designing an individual extraction study, which should reflect the unique purpose of that study - these include knowledge of the dosage form contained in the packaging system, the chemical composition of the packaging system and its individual components, along with experience based best practices. Attendees will be guided through these complexities by Dr. Norwood, who will also be on hand, along with the rest of the conference speakers, to answer any pertaining questions.
Further highlights of the conference include a focus on pre-filled syringes and simulated studies from Novo Nordisk and Toxikon, updates from ELSIE, IPAC-RS and BPSA, and new research on total organic carbon (TOC) reconciliation from VR Analytical. Plus, the pre-conference workshop, led by Dr. Andrew Feilden, Chemistry Operations Director at Smithers Rapra, will cover an introduction to extractables and leachables, material selection, risk based analysis and extractable and leachable testing. In addition to the two day program, poster sessions including a selection from the PQRI-PODP working group will allow attendees to hear even more about recent research and findings relating to all areas of E&Ls.