Qepler | summits & conferences | Extractables & Leachables Summit, 15-16 October 2019
Event Location:
Berlin, Germany
NH Collection Berlin Friedrichstrasse Friedrichstraße 96
15 October 2019 - 16 October 2019

Early Bird discounts:
Register early to save € 200 for the Individual ticket, € 300 per person for 2-3 Delegates, € 500 per person for 4+ delegates from the same company until 13 September 2019.

Contact Person: Evgenia Makar
Contact Person: Evgenia Makar, Qepler s.r.o.
Contact Person: Denis Polikarpov
Contact Person: Denis Polikarpov, Qepler s.r.o.

Conference Overview

Get the latest updates in regulation, analytical testing, risk & safety assessment, biocompatibility.

The featured talks on:

  • USP <665> draft standard: A rational risk-based approach to characterization of polymeric biopharmaceutical manufacturing systems.
  • Strategies for assessment of impurities and E&Ls.
  • Safety assessment of extractables/leachables: Challenges with different administration routes.
  • Toxicological assessment of non-genotoxic E&L.
  • Challenges and pitfalls during E&L studies and how to handle them.
  • Setting up effective E & L Studies: extraction and right conditions selection, leachable study monitoring and compounds selection, leachable study design.
  • Comparative Extractables Study of Autoclavable Polyethersulfone Filter Cartridges for Sterile Filtration.
  • Data Integrity.
  • Extractables and Leachables challenges of for prefilled syringes.
  • The rubber formulation composition and its impact on extractables and leachables.
  • Leachables strategies for finished biopharmaceuticals.
  • Adoption of standardized extractables datasets for single-use system qualification and risk assessment.

Meet our Speakers

Our Sponsors

Speaker Sponsor
Intertek (Schweiz) AG



Harshal Shah

Cambridge Consultants

chaired a panel discussion on the digitisation of clinical trials and next gen injectable devices, with speakers from Novartis, Roche, Janssen, Sanofi, SHL Group and Corvus Device.