Qepler | summits & conferences | 3rd Annual Extractables & Leachables Summit, Virtual Conference,  20-21 October 2021
Event Location:
Online Conference
20 - 21 October 2021

Conference Overview

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

The featured talks on:

  • Regulations and E&L: Regulatory Updates and Adoption, EMA, FDA, PQRI, ICH Guidelines, USP
  • Best Practices for E&L testing
  • Excelling E&L Strategy: Strategy Development, Analytical Method Selection and Validation, Chemical Profiles. Risk-Based Evaluation.
  • Building Effective E&L Study: Mapping Activities for the Development Phase, Techniques for the QC, Information Identification and Effective Use, Extraction and Right Conditions Selection, Leachable Study Monitoring and Compounds Selection, Leachable Study Design.
  • E&L Study Design: Main Changes, Action Plan, Step Wise Implementation.
  • Boosting E&L Assessment: Successful Strategy Implementation, E&L Study Design, Method Selection.
  • Successful Toxicological Risk Assessment Principles, Concepts and Tools. Substances Requirements, Effective Data Search, Safety & PDE. Substances with Poor Toxicological Information.
  • Quality Control, LCM, Change Management and E&L Testing: Qualification of Extractables & Leachables.
  • Extractables Data: Interpretation, Use, Exposure Identification, CCS, SUS.
  • Manufacturing Excellence: E&L minimisation, Risk-Based Evaluation, Testing Strategies, Single Use Equipment Selection.
  • Single-Use Systems: Risks Classification, Regulations Implementation in Study Design.
  • Packaging and E & L: Packaging Materials, USP Standards, Chemical Characterization, Quality Control, Process Development, Materials Selection.
  • Plastics and E & L: Classification, Types, Construction, Related Additives. Chemical and Physical Characteristics.
  • CCS & Materials: Practical Examples of Use of Different Types of Polymers. Polymers Composition.
  • Elastomers and E & L: E&L Assessment, Composition, Minimization Strategy.
  • Glass and E & L: Composition, Extractables Types, Risks Management and Evaluation, Extractables minimization. Glass Use in Parenterals and Associated Challenges.
  • Bioproduction and E & L: Related Issues, Manufacturing Process, Influence on the Stability, Storage, Administration.
  • Bioproduction view on the E & L evaluation: practical examples.
  • Combination Products and E&L: Regulations, Challenges Overcome, Risks assessment.
  • Lyophilized Products and E&L: Primary Packaging, Leachable Studies Design and Evaluation. Regulations Impact on Combinations Products in Administration Procedures: 21CFR Part 4.

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