Qepler | summits & conferences | 2nd Annual Extractables & Leachables Summit, Virtual Conference,  22-23 October 2020
Event Location:
Online Conference
22 - 23 October 2020
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:

  • E&L Considerations for Adoption of new Single-Use components: A Case Study with Millipak® Final Fill.
  • Top 5 Topics for inclusion in a future ICH document on Extractables and Leachables.
  • Minimizing E&L studies.
  • BioPhorum (BPOG) Extractable Recommendations for SUS – Final Chapter, and an end user’s data mining experience.
  • E&L Studies tailored for Transdermal Delivery Systems.
  • PQRI Final L&E Recommendations for Parenteral Drug Products and Practical Applications.
  • BPOG protocols.
  • Leachables an ICH guidance - Will the guideline be based on theoretical assessments or comprehensive analytical screening?
  • Choice of thresholds for Safety Concern Thresholds.
  • Fixing response factors for LC-MS and GC-MS.
  • Safety assessment of extractables/leachables: Challenges with ophthalmic administration routes.
  • Leachable Study design Space in Complex formulated Drug Products such as Biopharmaceuticals.
  • Similarities and differences between medicinal products and medical devices for Extractable and leachable testing.
  • The effect of X-ray and ClO2 sterilization techniques on Extractables & Leachables of Rubber Closures.
  • Assessing lot-to-lot variability of single-use devices by Extractables studies - are we hunting ghosts?
  • Analytical strategies for extractables and leachables.
  • Controlled extraction of single use Tubing - A Phthalate Case Study.
  • Influencing factors on Extractables and Leachables at different glass materials.

Meet our Speakers

Our Sponsors



3P Biopharmaceuticals, ES - Abbott Healthcare Products B.V., NL - Abbvie Deutschland GmbH & Co. KG, DE - Accord-UK Ltd, UK - Advent Consulting Canada, CA - ALK, DK - Alkermes Pharma Ireland Limited, IE - Alphamed Formulations PVT LTD, IN - Apotex Research Pvt Ltd., IN - Aspen Holdings, ZA - Aspen Pharmacare, ZA - B.Braun medical SA, CH - Bavarian Nordic, DK - Becton Dickinson, CN - Becton Dickinson, FR - Biogen, USA - Boston Analytical, USA - Claudia Cusa, d.i., IT - CSL Behring AG, CH - Datwyler Pharma Packaging International NV, BE - DuPont, USA - DuPont-Asahi Flash Spun Products, JP - EirGen Pharma, IE - Eli Lilly and Company, USA - EMS SA, CH - Eurofins Analytical Science Laboratories, Inc., JP - Fujifilm Diosynth Biotechnologies, UK - GSK, US - GSK Vaccines, BE - Hall Analytical, UK - Hemofarm AD, RS - HTL-Strefa S.A., PL - Intertek (Schweiz) AG, CH - Janssen, USA - Kora Healthcare, IE - LEO Pharma, IE - Maven E&L Ltd, UK - Medline Industries, USA - Merck KGaA, DE - MilliporeSigma a business of Merck KGaA, USA - Novartis, CH - Novartis Pharma Stein AG, CH - NOVAVAX CZ a.s., CZ - Orexo AB, SE - Orion Corporation - FI, Philips, NL - Polifarma İlaç San. ve Tic. A.Ş., TR - PPD, IE - Rentschler Biopharma SE, DE - Safetree Consulting e.U., AT - Sandoz Manufacturing Inc., CA - Sanofi, FR - Sanofi, DE - Sanofi Pasteur, CA - Sartorius Stedim Biotech GmbH, DE - SCHOTT AG, DE - SCIEX, UK - Selvita S.A., PL - Septodont, FR - SGS, CN-TW - SGS Institut Fresenius GmbH, DE - Solvias AG, CH - Sthree, BE - Swedish Biomimetics 3000 Ltd, UK - Takeda Pharmaceuticals, USA - Vet-Agro Sp. z o.o., PL - West Pharmaceutical Services, USA - Wockhardt Ltd, IN - and others.



AbbVie - AiCuris Anti-infective Cures GmbH - Angelini ACRAF s.p.a. - B. Braun - Bayer - Bayer AG - Borealis Polymere GmbH - Brooks Life Sciences - Claudia Heldt - Daicel Chiral Technologies (India) Pvt Ltd - Datwyler Pharma Packaging International NV - Datwyler Sealing Solutions - EirGen Pharma - Engelhard Arzneimittel GmbH & Co KG - F. Hoffmann-La Roche Ltd - GSK - GSK Vaccines - Hall Analytical Laboratories Limited - HTL-Strefa S.A. - Intertek (Schweiz) AG - Iterum Therapeutics - Lyomark Pharma GmbH - Maven E&L Ltd - Medichem - Merck - Merck KGaA - Nelson Labs - Novartis Institutes for BioMedical Research - Novo Nordisk - Pall Biotech - Patheon, by Thermo Fisher Scientific - PHARMIDEA SIA - Purus Plastics - RMS Foundation - Safetree Consulting e.U. - Sandoz - Sanofi - Sanquin Plasma Products - Sartorius Stedim Biotech - SAS Laboratoire Aguettant - SCHOTT AG - SE Tylose GmbH & Co. KG - SGS Institut Fresenius GmbH - Smithers Rapra Ltd. - Synthon Biopharmaceuticals BV - Vifor (International) AG - West Pharmaceutical Services GmbH & Co. KG - ZETA GmbH - Others