2nd Annual Extractables & Leachables Summit 2022 - uventia

2nd Annual Extractables & Leachables Summit 2022

March 30th  March 31st  2022



Extractables and leachables (E&L) assessment is a critical part in product development strategy. Regulatory bodies are very concerned about the interaction between pharmaceutical products and container closure systems, drug delivery devices, as well bioprocess manufacturing systems. Therefore, the migration of mobile chemicals from components and ingredients used in drug production and storage needs to be carefully evaluated.

Our online conference brings together scientists, toxicologists and managers to share the latest E&L analytical methods and strategies, regulatory updates and compliance, risk-based E&L programs, chemical characterization and toxicological risk assessment, material selection/screening/identification, uncertainty factors in E&L testing, analytical and safety thresholds, medical device materials and ISO 10993-18, customized methods for specific product types.

Participate in our virtual meeting and equip yourself with new tools to analyze and test for extractables and leachables in biopharmaceutical development – to effectively reduce E&L-related risks and ensure patient safety and product quality.


  • extractables and leachables assessment as a key component of product development and launch
  • accurate analytical methods for screening, identifying and quantifying of extractable and leachable compounds
  • practical experience of pharmaceutical experts in designing, implementing and reporting of E&L studies
  • reviews of recent regulatory updates to ensure compliance and cost-effective regulatory approvals
  • best practices for E&L material and chemical characterization and toxicological risk assessment
  • in-depth and compliant E&L assessments of complex materials, products and processes


CxO, VPs, Directors, Heads, Managers of

  • Extractables and Leachables/ E&L
  • Analytical Chemistry/ Analytical Development/Analytical Science
  • Product Characterisation/ Risk Assessment
  • Drug Development/ Drug Substance
  • Drug Safety/ Compound Safety/ Toxicology
  • Device Development/ Device Engineering/Container Development
  • Good Laboratory Practice (GLP)/Good Manufacturing Practice (GMP)
  • Manufacturing Science & Technology/ Single Use Systems
  • Bioprocessing/ Bioproduction
  • Regulatory Affairs & Compliance
  • Materials Science/ Materials Selection/ Biocompatibility
  • Packaging & Labelling
  • LC-MS/ Mass Spectrometry
Our Sponsors
Speaking Companies
Speaker Board
Paolo Grisostomi
Sr. Engineer, Materials Science
Douglas Kiehl
Research Advisor
Eli Lilly
Frances Sexton
Consultant Scientist
Eli Lilly
Steve Zdravkovic
Research Scientist II
Baxter Healthcare
Etienne Michel
Global QA for E&L
GSK Vaccines
Marine Lepoutre
E&L Global SME
GSK Vaccines
Wei Zhang
Manager, QC Analytical Sciences
Diane Paskiet
Director – Scientific Affairs
West Pharma
Roberto Menzel
Head of Extractables Laboratory
Reinhard Stidl
Senior Toxicologist - Managing Director
Safetree Consulting e.U.
Tino Otte
Head of Sales and Consulting
Intertek (Schweiz) AG
Clemens Guenther
Director, Senior Expert Nonclinical Safety
Bayer AG
Andrew Feilden
European E&L Strategic Director
Bicycle Therapeutics
Atish Sen
Staff Scientist

[Agenda] 2nd Annual Extractables & Leachables Summit 2022

Download the full summit program to find speaker biographies, case studies, key takeaways, the day’s schedule, and details of each session.

Previous Event

● 3M ● Aché ● Adjutant Solutions Group LLC ● AGC Biologics ● Albhades Provence ● ALK-Abelló S.A. ● Aptar Pharma ● AstraZeneca ● Athens Analysis Laboratories ● B.Braun Melsungen AG ● Baxter Healthcare ● Bayer AG ● BBraun Avitum Italy SpA ● Becton Dickinson ● Biogen ● BioNTech ● Boston Scientific ● BSC International Medical Trading ● Carl Zeiss Meditec AG ● Charles River ● Cytiva ● Dalton Chemical Laboratories Inc. ● Deva Holding A.Ş. ● Eli Lilly ● Eli Lilly & Co. ● Gador ● Galapgos NV ● Galderma ● Gilead Sciences ● GlaxoSmithKline Biologicals ● GlaxoSmithKline Biologicals Kft. ● Greiner Bio-One GmbH ● GSK Vaccines ● Hall Analytical ● HORIBA Scientific ● Incyte ● Incyte Biosciences Tech Ops ● Intertek (Schweiz) AG ● L.Molteni & C. dei F.lli Alitti SpA ● LGC Standards ● Lhasa limited ● Lonza ● Medela AG ● Merck KGaA ● Nelson Laboratories ● Niutec AG ● Norbrook Laboratories Ltd ● Norner AS ● Novartis Pharma AG ● Octapharma AB ● Par Pharmaceutical ● Pharma Mar ● Pliva Croatia Ltd. ● PLIVA Hrvatska d.o.o. ● QUINTAANALYTICA s.r.o. ● Regeneron ● Safetree Consulting e.U. ● Sandoz ● Sanofi ● Sanofi-Aventis ● Sanofi-Aventis R&D ● Sartorius ● Sartorius Stedim Biotech GmbH ● Sumitomo Dainippon Pharma Co., Ltd. ● Takeda Pharmaceutical Co. Ltd. ● Teva Pharmaceutical Industries LTD ● Teva Pharmaceuticals Ireland ● TRIS Pharma ● UCB Biopharma SRL ● Waters Corporation ● Waters GmbH ● West Pharmaceutical Services ● Xellia d.o.o.

● AbbVie, Inc. ● Albhades Provence ● Altran ● AryoGen Pharmed ● AstraZeneca ● B. Braun Medical AG ● Bayer AG ● Bio-Technology General (Israel) Ltd. / Ferring Pharmaceuticals ● Biogen ● Boehringer Ingelheim ● Butterworth Laboratories Ltd ● Carso ● Cenexi ● Chemo SA ● Chiesi Farmaceutici spa ● CMIC Pharma Science Co.,Ltd. ● Constantia Patz Ges.m.b.H. ● ConvaTec ● CSL Behring AG ● ELPEN Pharmaceutical Co. Inc. ● GSK ● GSK Vaccines ● Hall Analytical ● Illumina ● Imperial Brands ● Incyte ● Intertek (Schweiz) AG ● Intervenance NG ● Jagiellońskie Centrum Innowacji ● Laboratorio Reig Jofre, S.A. ● Lonza ● Lonza DPS ● Medtronic LTD. ● Merck Healthcare KGaA ● Merck Serono ● Microvention Inc. ● Minapharm Pharmaceuticals ● National Institute for Bioprocessing Research and Training (NIBRT) ● Nelson Labs Europe ● NNE ● Norner AS ● Novartis ● Octapharma ● Pharma Quality Europe srl ● PHARMA-DATA S.A. ● Polpharma ● ProPharma Group ● Regeneron ● S&C BEST Srl ● SaniSure ● SCIEX ● SGD Pharma ● Solvias AG ● Swissmedic ● Synthon Hispania ● Takeda ● Takeda Pharmaceuticals ● Taro Pharmaceuticals inc. ● Teva Pharmaceuticals ● UAB Teva Baltics ● UCB Biopharma SRL ● Viatris ● Waters Corporation ● Watson-Marlow Fluid Technology Group ● WuXi Biologics ● Xellia Pharmaceuticals

Event Details