This conference brought together the pharmaceutical supply chain to discuss the latest research and development in minimising the risk posed by Leachables and Extractables. Parenterals, implantables, inhalers or solid dose packagingthis conference covered what you need to know.

Paper 1 Additives in and polymer processing of pharmaceutical packaging

SESSION 2 REGUALTORY LANDSCAPE
Paper 2 Leachables and extractables: regulatory issues in the medical device industry
Ron Pagan, Medicom Consulting Ltd, Ireland

SESSION 3 BEST PRACTICE GUIDEINES
Paper 3 PQRI: safety thresholds and best practices for extractables and leachables in orally inhaled and nasal drug products
Douglas J Ball, MS, DABT, Pfizer Inc, USA

Paper 4 The analytical evaluation threshold (AET) concept: sensitivity and analytical uncertainty
James D Mullis, Boehringer Ingelheim Pharmaceuticals Inc, USA

Paper 5 Extractables and leachables best practice guidelines
Keith Scott, Smithers Rapra Technology Ltd, UK

Paper 6 Meeting the challenges of implementing PQRI guidelines with respect to routine extractables methods for OINDP in a high volume manufacturing environment
Stuart Pattinson & John Colwell, Bespak Europe Ltd, UK

SESSION 4 APPROACHES TO LEACHABLES & EXTRACTABLES TESTING: CASE STUDIES
Paper 7 Analytical methods for extractables and leachables studies: case studies
Dr Michael Jahn, Ciba Speciality Chemicals Inc, Switzerland

Paper 8 Analytical approaches for extractable and leachable testing
Dr Andrew Feilden, Astrazeneca, UK

Paper 9 Extractables and leachables for pharmaceutical products: a practice approach
Dipl-Ing Heike Schulz, West Pharmaceutical Services Deutschland GmbH, Germany

Paper 10 A case example of leachable and extractable testing for containers used for veterinary products
Cathyln Carley, Novartis Animal Health, Switzerland

SESSION 5 QUALITY
Paper 11 Managing hybrid quality systems
Diane Baker, Smithers Rapra Technology Ltd, UK

SESSION 6 SUPPLY CHAIN CONSIDERATIONS
Paper 12 Points to consider on extractables and leachables during OINDP development
Dr Andy Rigby, Astrazeneca, UK

Paper 13 Resin manufacturers perspective on pharmaceutical industries packaging needs to comply with extractables and leachables legislation
Hanneli Seppanen, Borealis Polymers OY, Finland

Paper 14 A strategy for extractives and leachables evaluation to minimise risk when changing materials in primary packaging components
Simon Bailey, Sanofi Aventis, UK

Paper 15 Innovative thermoplastic materials for healthcare applications
Rob de Jong, Sabic Innovative Plastics, The Netherlands

Paper 16 Optimisation of sampling from a plastic material for extractables testing
Stephane Burel, Valois, France

SESSION 7 CASE STUDIES
Paper 17 Metered dose inhaler extractable and leachable study designs
Graham Wilson, GlaxoSmithKline Research & Development, UK

Paper 18 Material and product evaluation
Maygon Wendel Lesenius, Gambro AB, Sweden