Event Agenda

Below is the 2019 agenda outlining topics discussed at the annual Extractables & Leachables China conference.

Monday 23 September

Food contact training workshop

  1. Food Contact Training led by Marco Zhong, Director, National Reference Laboratory for Food Contact Material

    Marco Zhong | Director of National Reference Laboratory for Food Contact Material (Guangdong) Inspection and Quarantine Technology Center, China

    08:30 - 09:00 Registration and welcome refreshment

    09:00 Food contact training workshop

    Overview of food contact regulations across the globe

    • Key principles and approaches
    • Key similarities and differences across regions
    • Steps towards and challenges with Harmonisation         

    10:15 Networking coffee break 

    • Overview of Food Contact regulations in China
    • Introduction to Chinese food contact regulations
    • Achieving regulatory approval in China
    • Future regulatory outlook
    • Panel discussion

    12:30 Workshop ends

     

    Tickets to the Food Contact Training workshop are not included in the main conference ticket price, there is an additional cost of $399 should you wish to take part in this activity.

Extractable and Leachable masterclass

  1. Extractable and Leachable masterclass led by Dr. Feilden and Dr. Norwood, Smithers

    09:30 Registration and refreshment break
    10:00 - 16:00 E&L masterclass 

    Provisional workshop schedule 

    Introduction to Extractables and Leachables

    • Definitions and key terms
    • General regulatory requirements
    • Working Groups and guidance documents 

    11:30 Morning networking break

    Extractables assessments

    • Best practices – general consensus
    • Case studies
    • Advanced topics

    Leachable assessments

    Best practices – general consensus
    Limits based on safety
    Safety assessment and qualification

    13:00 - 14:00 Networking lunch 

    Regulatory considerations

    • Drug product requirements
    • Combination products
    • Medical devices ISO10993
    • Breathing pathways ISO 18562
    • Future regulatory trends

    Concluding thoughts

    16:00 End of workshop 

    Tickets to the E&L Masterclass are not included in the main conference ticket price, there is an additional cost of $399 should you wish to take part in this activity

Tuesday 24 September

Tuesday 24 September

  1. Registration and welcome refreshment

  2. Chairman’s opening remarks

Session 1 - Regulatory landscape and updates

  1. ISO 10993-18: chemical characterisation of medical devices; latest developments and expectations

    Ted Heise | Vice President, Regulatory & Clinical Services of MED Institute, USA

    • The current version of ISO 10993-18 was published in 2005; a lot has happened since then.
    • For 5 years the document has been under heavy revision, and this talk will describe the latest developments.
    • Attendees will be given a high level overview of the chemical characterization process.
    • The talk will describe topics that have been particularly challenging, including latest expectations from FDA.
    • A case study will provide insight on the process from lessons learned in practical application
  2. The USP position on the use of polymers in pharmaceutical applications including packaging and manufacturing components

    Dr. Dennis Jenke | Chief Executive Scientist of Triad Scientific Solutions, UK

    • USP Chapters for Polymers Used in Packaging
    • USP Chapter <665>; Materials and Components Used in Pharmaceutical Manufacturing Systems
    • USP Chapters <1663> and <1164> for Extractables and Leachables
  3. Chinese regulatory perspective on E&L guidelines

    Speaker to be confirmed

    • What are the application expectations / packaging material regulations? What kind of testing is expected for packaging approval?
    • What are the requirements given from the CFDA (Chinese-FDA)?
  4. Panel - Alignment of regulations and their impact on E&L assessment

    • What are the differences in regulation and requirements for US/EU vs China/Japan?
    • How to align global guidelines?
    • How European suppliers/CROs understand the requirements and interpretation of these guidelines in order to succeed and thrive in China; How they register packaging in China
    • ICH guideline – E&L proposal

    Panellists include:

    • Carsten Worsøe, Principal Scientist Extractables and Leachables, Novo Nordisk
    • Dr. Dennis Jenke, Chief Executive Scientist, Triad Scientific Solutions
    • Ted Heise, Vice President, Regulatory & Clinical Services, MED Institute

    More panellists to be announced

  5. Morning networking break

Session 2 - Analytical challenges in E&L

  1. Analysis of leachable substances for medical biomaterials

    Zhang Li | Senior Engineer of CFDA Hangzhou Medical Device Testing Center, China

  2. Challenges and examples of identifying unknown extractables/leachables: What is an unknown?

    Dr. Daniel Norwood | Executive Partner of SCIO Analytical & Senior Consultant at Smithers Rapra, UK

  3. Identifying and mitigating errors in organic extractables/leachables screening

    Dr. Dennis Jenke | Chief Executive Scientist of Triad Scientific Solutions, UK

  4. Networking lunch

  5. Challenges of E&L study under changing regulatory environment

    Lynn Yao | Scientific Affairs Manager, China of West Pharmaceutical Packaging (China) Co., Ltd.

  6. Interactions between leachables and pharmaceutical drug products – a myth or a fact?

    Carsten Worsøe | Principal Scientist Extractables and Leachables of Novo Nordisk

    Carsten Worsøe
  7. Extractables and leachables identification and assessment for silicone tubing used in manufacturing

    Yi Zhang | Laboratory Director of Guangzhou BrunsLab Co., Ltd., China

    • E&L Study design based on current China regulatory authoritiy’s requirements
    • Recommendation for supplier evaluation and selection
    • Effect of manufacturing process conditions on extractables from silicone tubing
  8. Challenges using multiple single-use systems: functionality versus extractables and leachables

    Queenie Gai | Manager, China E&L Laboratory BioReliance® Validation Services of Merck, China

  9. Afternoon networking break

  10. Contact lenses extraction research

    Chen Ping | Head of R&D Department of Haichang Contact Lens Co. Ltd., China

    • The purpose of material extraction research
    • Exploration of extraction method
    • Research content of Extraction, safety evaluation
  11. Biological safety evaluation of drug device combination products within ISO 10993-1 (2018) risk mana

    Sharlene Dai | Sr. Principal Toxicologist of Medtronic, USA

    • Practical challenges of biological risk assessment throughout the product life cycle
    • Overall strategy for successful regulatory submissions:  evaluation and testing
    • Case studies
  12. Analysis of respiratory medical devices according to ISO 18562

    Dr. Nikhil Sahotra | Materials Emission Market Specialist of Markes International, UK

    • ISO 18562 overview
    • Analysis of volatile chemical released in breathing gas pathway
    • Thermal desorption-Gas Chromatography
    • Enhancing E&L analysis using high-capacity sorptive extraction
  13. The role of E&L in the ISO 14971 risk management process

    Dr. Zhenxia Du | Professor, Center of Analytical Chemistry and Testing of Beijing University of Chemical Technology, China

  14. Chair’s closing remarks

  15. Networking drinks reception

    18:00-19:30 Networking drinks reception 

Wednesday 25 September

Wednesday 25 September

  1. Registration & welcome refreshments

  2. Chairman’s opening remarks

Session 3 - Focus on medical devices

  1. Designing chemical characterisation studies to meet changes to ISO 10993

    Sandi Schaible | Senior Director, Analytical Chemistry and Regulatory Toxicology of WuXi AppTec, USA

    • Overview of 10993 changes are they relate to chemical characterization
    • Designing an extraction study
    • Considerations for analytical methods (determining the AET and identifying unknowns)
  2. Chemical characterisation of acrylonitrile butadiene styrene 3D printed medical devices

    Keaton Nahan, Ph.D. | ORISE Fellow at Center for Devices and Radiological Health of U.S. FDA

  3. How to choose an appropriate simulation solvent for medical device assessment? - A case study of DEHP analysis for blood-contacting device

    Luo Hongyu | Senior Scientist of Baxter Healthcare Company, China

  4. Networking break including poster session in the exhibition hall

    Attend the poster session in the exhibition hall to find out about cutting-edge E&L science and put your questions to the authors

  5. Update on the progress made to revise ISO 10993-17

    Dr. Sherry Parker | Toxicology Director of WuXi AppTec, USA

Session 4 - Focus on packaging

  1. Evaluation strategy for comparability of container closure system

    Fangfang Zhang | Senior Engineer, Deputy Director of Analysis Department of Shanghai Food and Drug Packaging Material Control Center, China

    • Technical Requirements for Comparability of Listed Chemical generic Drugs (Injections) put forward the requirement for container closure system.
    • From the perspective of case studies, the comparability and safety of container closure system was provided based on AET.
    • The inorganic extractables, semi-volatile organic extractables, non-volatile extractables and volatile extractables of container closure system were screened and compared by ICP/MS, GC/MS, HPLC/MS and HS/GC/MS.
    • Methods for restricted substances are established for the specific substances of elastomeric seals, such as nitrosamines and others.
  2. E&L study for pre filled syringe

    Kathy Huang | R&D Manager of Becton Dickinson Medical Devices (Shanghai) Co. Ltd., China

  3. How to perform safety assessment of parenteral drug products via appropriate experimental design – exhaustive extraction vs. simulation extraction

    Xiaoxia Ye | CTO of Tiankun Pharma, China

    • General considerations of extractable experimental design for parenteral drug products
    • Benefits of exhaustive extraction and simulation extraction
    • Case studies (e.g. sleeve stopper, LDPE container): exhaustive extraction vs. simulation extraction (leachable data will be presented)
  4. Networking lunch

Session 5 – General topics

  1. How to properly design and execute extractables assessment on print foil

    Weichun (Wes) Yang | Senior Manager of Baxter, China

  2. Organic small molecule fluorescent probe and its application in rapid detection of metal Ions

    Zhengjian Qi | Professor and Doctoral Supervisor of School of Chemistry and Chemical Engineering, Southeast University, China

  3. Submissions to the FDA: what to watch out for from a CRO perspective

    Dr. Piet Christiaens | Scientific Director of Nelson Labs NV

    Piet Christiaens
  4. The role of E&L in the ISO 14971 risk management process

    Dr. Zhenxia Du | Professor, Center of Analytical Chemistry and Testing of Beijing University of Chemical Technology, China

  5. Chair’s closing remarks

  6. End of conference