Annual Extractables and Leachables Summit

This premier event provides the appropriate platform to discuss and network with peers involved in pharmaceutical manufacturing, toxicology, quality control, devices, single-use systems, equipment and container development.

The summit will shed light on guideline updates, analytical testing innovations, and the impact of E&L on biologics safety.

It is an honour and privilege to invite you to participate in this Summit. We look forward to welcoming you at the Summit in Berlin this coming October!

Key Practical Learning Points of the Summit:

  • Regulatory considerations and working group updates
  • Single Extractable standard (BPOG, USP and ASTM)
  • Standards and validation
  • Innovations in analytical techniques
  • E&L in quality control
  • Extractables and Leachables considerations for single-use systems
  • Pharmaceutical materials characterisation
  • Toxicological evaluation of Leachables
  • Regulatory requirements and expectations

Who Should Attend:

Chief Executives, Directors, Vice Presidents, Department Heads, Leaders, Senior Managers, Scientists, Chemists, Engineers and Fellows specialising in:

  • Bioprocessing
  • Container development
  • CMC
  • Device Engineering
  • Extractables and Leachables/ E&L
  • Formulation
  • Licensing
  • Materials Science
  • Materials Selection
  • Manufacturing Science and Technology
  • Medical Devices
  • Parenterals
  • Packaging and labelling
  • Product and Process Development
  • Pharmaceutical Analysis
  • QA/QC
  • Risk management
  • Regulatory Affairs
  • Safety Assessments
  • Scientific Affairs
  • Standardisation
  • Testing
  • Toxicology
  • Validation


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