Contents -- THE REGULATORY STANDPOINT -- Paper 1 Introduction to extractables and leachables -- Paper 2 Regulatory perspective -- UPDATES FROM INDUSTRY WORKING GROUPS -- Paper 3 PQRI-PODP working group update -- Paper 4 The United States Pharmacopeia and the issue of leachables and extractables: past, present and future -- Paper 5 Risk management concepts and strategies applied to materials quality -- E&L APPLICATIONS & CONSIDERATIONS -- Paper 6 Risk Based Assessment of Extractable and Leachable Substances from Single-Use Systems Including case studies -- Paper 7 Product equivalency for medical devices -- case studies for biodegradable and permanent implantable devices -- Paper 8 Extractable and leachable studies of twist-off ports (T.O.P.) used for blood pack containers -- E&L CASE STUDIES ON PARENTERALS -- Paper 9 E&L's from elastomeric components for parenteral packaging: Understanding the impact of process parameters and sterilization methods -- Paper 10 Extractable and leachable study of container closure/delivery systems for parenteral medications -- TOXICOLOGICAL PERSPECTIVES ON E&LS -- Paper 11 Determining acceptable levels of leachables into pharmaceutical products - a toxicological perspective -- Paper 12 Case studies of toxicology risk assessment of extractables and leachables -- Paper 13 Current status of the ELSIE -- demonstration of the practical use of the ELSIE safety database for the rapid assessment of risk from a controlled extraction study -- MATERIALS COMPOSITION AND QUALITY -- Paper 14 Correlating material composition to extractables and then to leachables -- Paper 15 Characterization of E&L associated with pharmaceutically relevant materials: some analytical challenges and case studies -- CHALLENGES IN E&L STUDIES -- Paper 16 (Halo)butyl rubber oligomers in pharmaceutical rubbers.

Paper 17 Case studies relating to implantable medical device and biologic products -- Paper 18 Analytical challenges associated with high toxicological risk compounds (Nitrosamines): Raising the Safety Concern Threshold.