E&L 2011 Agenda

Conference Day 1 - Wednesday 7 December 2011

08.00 Registration and refreshments

09.00 Opening remarks from the Co-Chairs
Dr Carsten Worsoe, Research Scientist, NOVONORDISK, Denmark
Thomas Egert, Chemical Characterisation, Drug Delivery Department, BOEHRINGER INGELHEIM PHARMA, Germany

09.10 Opening keynote: The European regulatory perspective on extractables and leachables from pharmaceuticals
Anna Valeri, Pre-Clinical Assessor, MHRA, UK

09.45 The parallels and differences between food, medical and pharmaceutical regulations
- A overview of regulations regarding contact materials in different regulatory environments
- Overlap of regulations, guidelines, best practice and material selection
- A comparison of the "in-practice" approaches to demonstrate compliance in each environment
- Testing strategies used in the different environments.
Michael Creese, Senior Consultant, SMITHERS RAPRA, UK

10.20 Networking refreshment break

11.10 Update on the status of PQRI PODP efforts to develop best demonstrated practices for extractables testing and toxicological assessment
- E&L Qualification: from orally inhaled and nasal drug products (OINDP) to PODP
- Working group hypothesis
- Unique aspects of PODP materials and dosage forms
- Key points of E&L best practices for PODP
- Approach to toxicological assessment of PODP leachables
- E&L qualification in the light of quality by design
Thomas Egert, Chemical Characterisation, Drug Delivery Department, BOEHRINGER INGELHEIM PHARMA, Germany

11.45 Contact materials compatibility with biologics: Strategy and case studies
- Examination of key decision points to assess the risk of packaging coming into contact with a vaccine
- Case studies of leachable studies
- Interpretation of results
- Development of alternate approaches in order to meet regulatory expectations
Dr Alda Laschi, Analytical Expert, Corporate Quality, SANOFI PASTEUR, France

12.20 Leachables from semipermeable and impermeable ophthalmic drug packaging
- Discussion of extractables and leachable concerns unique to ophthalmology
- Case studies on packaging leachables observed from semi-permeable and impermeable ophthalmic packaging systems
- Discussion of risk minimization approaches for selecting ophthalmic packaging materials
Dr Christopher Houston, Senior Principal Scientist, Analytical Investigations, Pharmaceutical Technical Services, BAUSCH AND LOMB, USA

12.55 Lunch will be served for all speakers and delegates

14.15 Insights into the identification, qualification and utilization of external resources for E&L studies and into the genesis and use of the Safety Assessment Triad
- The difference between procuring capacity and expertise
- Factors to consider in identifying potential external resources
- The technical qualification process and essential questions to ask
- Purpose, genesis, evolution and customization of the Safety Assessment Triad
Dennis Jenke, Baxter Distinguished Scientist, BAXTER HEALTHCARE, USA
(to be delivered remotely)

14.50 E&L's from administration systems from parenterals
- Relevance for E&L testing of administration systems for parenterals
- Current and past E&L requirements for continuous infusion systems
- Questions raised from Health Authorities with regards to E&L of administration systems
- Case studies of E&L's from administration systems
Dr Carsten Worsoe, Research Scientist, NOVO NORDISK, Denmark

15.25 Networking refreshment break

16.00 Determination of extractables/leachables from single-use systems as part of process validation
- Presentation of a case study
- Understanding the steps of the parametric study
- Benefits of this risk-based approach
Dr Sade Mokuolu, Technical Manager, PALL LIFE SCIENCES, UK

16.35 Material supplier requirements: theory versus reality
- Requirements for material suppliers
- Presentation of case studies
- A comparison of theoretically derived requirements with reality
Dr Bert Schatowitz, Head of Analytical Testing, INTERTEK EXPERT SERVICES, Switzerland

17.10 Closing remarks from Co-Chairs

17.40 Depart for networking social programme

 

Conference Day Two - Thursday 8 December 2011

08.30 Registration and refreshments

09.00 Opening remarks from the Co-Chairs
Dr Carsten Worsoe, Research Scientist, NOVONORDISK, Denmark
Michael Creese, Senior Consultant, SMITHERS RAPRA, UK

09.05 Contract Research Organisations, providing E/L-support: the necessity to develop supporting R&D-programs
- Developing a screener database for high level identifications
- Organic synthesis/isolation of frequently observed and non-commercially available standards
- Generating experimental toxicological data for uncommon E/L-compounds
- Further R&D in support of the "first pass" testing: a general strategy
- R&D for E/L: some case studies
Dr Frank De Smedt, Department Head Analytical Services, TOXIKON EUROPE, Belgium

09.40 High throughput screening - An MS based approach for extractables & leachables studies
- Understanding automated high throughput LC/MS target screening
- Parallel (visual) non target LC/MS target screening of extractables
- Confirmation or accurate mass hits via MS/MS data and retention time
- Comparison of LC/MS hits with semiquantitative GC/MS data
Dr Karl Abele, Project Leader, SOLVIAS AG, Switzerland

10.15 Comprehensive extractables and leachables strategy and case study of an HFA metered dose inhaler drug product
- Case study of an MDI product
- Leachables method development and validation
- Specification development for leachables
- Correlation of extractables and leachables
- Successfully using supplier provided Information for extractables
Dr Alan D. Hendricker, Principal Scientist, CATALENT PHARMA SOLUTIONS, USA

10.50 Networking refreshment break

11.20 Extractables - a polymer producer's point of view
- Working to address the information gap.
- Looking from a polymer science point of view
- Insights into an extractable testing programme
- Topical case-study
Dr James Stern, Global Business Development Manager, Healthcare Applications, LYONDELLBASELL, UK

11.55 Investigation of extractables in elastomeric materials for pharmaceutical applications - a rubber manufacturer's approach
- Raw materials; oligomers, antiageing agents, stabilizers, coating of fillers, softeners and crosslinking agents
- Reaction products of the crosslinking (rubber curing)
- Influence of post treatment (washing, oxyglazing, sterilisation)
- Suitable analytical methods for the different types of extractables
Dr Andreas Schatzinger, R & D Pharmaceutical Compounds, LONSTROFF AG, Switzerland

12.30 Primary packaging materials for DPIs; how can extractables profiles help to optimize material structures?
- From standard to customized structures: how to fulfill technical requirements?
- Comparative extractable investigation on different contact layer
- Influence of material selection on final AET and QT
Peter Claessens, Project Leader for Packaging Development, and Dr Thorsten Schmeck, Project Manager - Analytical Chemistry, AMCOR FLEXIBLES, Germany

13.05 Closing remarks from Co-Chairs

13.10 Close of conference and lunch to be served for all speakers and delegates