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Abstract Submissions

We are now accepting abstract submissions from those wishing to speak at Extractables and Leachables China 2020, taking place this December.

If you would like to speak on any of the below themes or another topic related to E&L, we'd like to hear from you:

  • Global regulatory landscape and updates on E&L
  • Requirements of NMPA on E&L Reports
  • Updates on ICH Q3E development and the challenges faced
  • Standard interpretation: USP 665 and 1665
  • Comparison among requirements worldwide: NMPA, FDA, USP etc.
  • Insights and perspectives from pharma and biotech companies
  • E&L challenges on drug products
  • BPOG E&L SUS – the final chapter
  • E&L in pharmaceutical packaging and manufacturing systems
  • Standardized procedure of pharmaceutical packaging extracting and analysis
  • E&L in manufacturing systems
  • E&L in medical Devices
  • Guidance from Center for Medical Device Evaluation (CMDE) of NMPA
  • Overview and interpretation of the Revised ISO 10993 Part 18
  • Challenges facing chemical characterization application in medical devices
  • Challenges in E&L profiling: Identification
  • Challenges in E&L profiling: Quantitation
  • Toxicologists on safety assessment
  • Toxicological assessment for special chemicals
  • Criteria of judgement on safety assessment – a toxicologist perspective
  • Trends in E&L development
  • Experimental designs for E&L studies
  • Experimental designs for leachables study of direct contact and implantable devices
  • Overall control and Integrated idea needed when design testing scheme
  • Method development and validation for E&L study
  • Challenges and technical advances on E&L analysis
  • New technologies on E&L studies
  • Genotoxic Leachables: how to determine and test it at very low limit
  • Focus on materials and biomaterials
  • Risk assessment on elastomer closures
  • Consideration on raw materials for medical devices from suppliers’ perspective
  • E&L in vaping

Please submit your abstract via the form below. We are accepting submissions in both English and Mandarin.

Should you have any questions, please contact the conference producer Nancy Yao at   nyao@smithers.com  or on +86 180 5109 2296.

Submit Your Abstract