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Online Workshop: Extractables & Leachables for Medicinal Products

Date: Thursday 11 November 2021

Time: 09:00 - 13:00 GMT

Location: Online

Price: Tickets: €349 + VAT

Workshop Agenda

09:00 Introduction to Extractables and Leachables

  • Origins of E&L
  • Terminology

09:45 Regulatory - FDA; EMEA etc

  • Regulatory structure
  • PQRI, USP
  • Thresholds
  • Combination products

10:45 Break

11:00 Chemical characterisation, Extractables, Leachables

  • Best practices
  • Study design
  • Toxicological evaluation - where does this fit in?

12:00 Experimental

  • Techniques: GC-MS/LC-MS/ICP/SH GC-MS etc.
  • Interpretation of results
  • Method development/validation
  • Dealing with unknowns
  • Toxicology again

Workshop Leaders

EL-EU-2021-P-Cummings-Workshop-Card
EL-EU-2021-K-Scott-Workshop-Card
EL-EU-2021-C-Bellis-Workshop-Card-NEW