E&L USA Conference Agenda
Conference Day One - Wednesday May 16
8.00 Registration and breakfast
9.00 Opening remarks from Co-Chairs
Sukhy Toot, Product Manager for Medical and Pharmaceutical Services, SMITHERS RAPRA, and William Beierschmitt, Regulatory Strategy Lead, Drug Safety Research & Development, PFIZER, USA
Setting the scene
9.10 Introduction to extractables and leachables
Dr Andrew Feilden, Principal Consultant, SMITHERS RAPRA, UK
9.55 Extractables and leachables from CCS: Life-time management and patient safety considerations for parenteral and ophthalmic drug products
Kumudini Nicholas, Advisor/Team Leader, Pharmaceutical Quality Review, Generic Drugs Quality Division, Bureau of Pharmaceutical Sciences, Therapeutic Products Directorate, HEALTH CANADA, Canada (to be delivered remotely)
10.30 Networking refreshment break in the exhibition hall
Working group updates
11.10 PQRI PODP Working Group Update: "What's good for OINDP may not be good for PODP" 
- Organization of PQRI
- OINDP Hypothesis testing results
- Application to PODP
- PODP Hypotheses
- Chemistry, toxicology and PODP Laboratory Work
- Building sound scientific justifications and consensus
Dr Thomas Feinberg, Director, Development & Clinical Services, CATALENT PHARMA SOLUTIONS, and PQRI representative, USA
11.45 A discussion of the Chemical Assessment Triad and its application to packaging systems safety assessments
- Genesis of the Chemical Assessment Triad; link to the product development cycle
- The Triad as a strategic outline for chemical safety assessment
- Components of the Triad; material characterization, simulation study, product assessment
- The Triad as a means for correlating ingredients, extractables and leachables.
- Using the Triad to address when is a safety assessment complete?
Dennis Jenke, Baxter Distinguished Scientist, BAXTER HEALTHCARE, USA
12.20 How can knowledge space concepts be applied to extractables and leachables management in OINDP?
Cheryl Stults, IPAC-RS representative, Senior Fellow, NOVARTIS PHARMACEUTICALS CORP. USA
12.55 Lunch will be served for all speakers and delegates
2.10 Extractables and leachables - the toxicologists perspective
- Why is the topic of Extractables and Leachables important to the Toxicologist?
- What is the toxicologist's role during the development of extractable and leachable data?
- What procedures and practices does a toxicologist use to assess the safety of these chemicals?
- Case examples demonstrating the role of the toxicologist in assessing the safety of these chemicals
William Beierschmitt, Regulatory Strategy Lead, Drug Safety Research & Development, PFIZER, USA
2.45 Toxicologists collaborating with chemists to optimize safety assessments of leachables and extractables for orally inhaled pharmaceuticals
- Key collaboration steps between toxicologists and chemists from early material selection to late stage evaluation
- The importance of establishing Analytical Evaluation Thresholds (AETs) and ongoing dialog on appropriate identification needs
- Practical examples of safety assessment using the threshold concepts (SCT and QT) and augmented with other risk assessment tools
- Case studies of representative compounds found in MDIs and DPIs
Ron Wolff, SAFETY CONSULTING INC, USA
3.20 Networking refreshment break in the exhibition hall
Material Considerations
3.50 Facilitating extractables and leachables testing using a preliminary materials assessment
- Polymer de-formulation / additive analysis
- Typical extractables profiles for plastic and elastomers
- Sources of unexpected migrants
- Polymer supply chain management
Dr Michael Ruberto, President, MATERIAL NEEDS CONSULTING LLC, USA
4.25 Parenteral product quality - A Toxicologist's story of material assessment
- The importance of a toxicologist's involvement in setting requirements for material limits
- Examples of a risk-based toxicology approach to informing E/L strategies in parenteral products manufacturing
Robert A. Jolly, Consultant Toxicologist, Risk Assessment, Health, Safety & Environmental group, Lilly Research Laboratories, ELI LILLY & CO, USA
5.00 Closing remarks
5.10 Networking drinks reception, sponsored by 
Conference Day Two - Thursday May 17
8.00 Registration and breakfast
9.00 Opening remarks from Co-Chairs
Dr Andrew Feilden, Principal Consultant, SMITHERS RAPRA, UK and Cheryl Stults, IPAC-RS representative, USA
Assessment of Extractables and Leachables
9.05 The European regulatory perspective
- When is toxicological assessment of E&L necessary?
- Existing EU guidance and regulatory framework
- Information required for submission in a marketing authorisation application and variation
- Carrying out a risk assessment
- Example of deficiencies
Dr Dima Al-Hadithi, Senior Pharmaceutical Assesor, MHRA, UK - to be delivered remotely
9.40 Application of automated Solid Phase Extraction (SPE) LC/NMR and solid state NMR (ssNMR) to extractables profiling
- Automated Solid Phase Extraction (SPE) LC/NMR optimized with model compounds, and chromatographic peak isolation and further analysis by high-field cryoprobe NMR.
- Solid state NMR (ssNMR) analysis of cryoground primary packaging component materials showing direct analysis of potential extractables
Dr Daniel Norwood, Distinguished Research Fellow, BOEHRINGER INGELHEIM PHARMACEUTICALS, USA
10.15 Assessing extractables and leachables for implantable medical devices to satisfy the PMA and 510 (k) filing requirements
- Challenges for analytical evaluation of a long term implantable medical device for extractables and leachables
- Method development issues and solutions for trace level degradation products related to antioxidants
- Sterilization process related degradation
- Key points for method validation
- Leachable testing using biologically relevant extraction media
Gyorgy Vas, Principal Scientist, Analytical Research and Development,
JOHNSON&JOHNSON, PRODUCT AND PROCESS SCIENTIFIC SOLUTIONS, USA
10.50 Networking refreshment break
11.30 Does the re-use of filling tubes for pharmaceutical products affect the E&L properties of the filling tubes?
- Introducing the term absorbable
- Effect of processing of filling tubes
- Case studies on E&L from filling tubes
Dr Carsten Worsoe, Principal Scientist, NOVONORDISK, Denmark
12.05 Leachables from semipermeable and impermeable ophthalmic drug packaging
- Review of FDA expectations for ophthalmic drug products and a comparison with the PQRI-OINDP recommendations
- A case study of a polyfoil tube for an ophthalmic ointment
- A case study of a leachable from secondary packaging
Christopher Houston, Senior Principal Scientist, Analytical Investigations, Pharmaceutical Technical Services, BAUSCH+LOMB, USA
12.40 Lunch will be served for all speakers and delegates
More Material Considerations
2.00 In-Vitro toxicological evaluation of materials; could a "Modified AMES" test assist in the initial material selection for the development of pharmaceutical containers?
Dr Piet Christiaens, Scientific Director, TOXIKON EUROPE, Belgium
2.35 Considerations concerning change management
- Considerations for changes in supplier materials for already marketed or even later development stage products
Sukhy Toot, Product Manager for Medical and Pharmaceutical Services, SMITHERS RAPRA, USA
3.10 Closing remarks from Co-Chairs
3.15 Close of conference