3rd Annual Extractables & Leachables Summit 2023 - uventia

3rd Annual Extractables & Leachables Summit 2023

March 9th  March 10th  2023

VIRTUAL CONFERENCE

CONFERENCE OVERVIEW

Evaluation of extractables and leachables (E&L) is a crucial step in the plan for product development. The interaction of pharmaceutical products with container closure systems, drug delivery devices and bioprocess manufacturing systems is a major concern for regulatory agencies. So, it is important to thoroughly assess the migration of mobile molecules from the components and substances used in the manufacture and storage of drugs.

Our virtual conference brings together scientists, toxicologists and E&L managers to discuss the most recent analytical strategies, regulatory updates, risk-based E&L programs, chemical characterization and toxicological risk assessment. We also bring up uncertainty factors in E&L testing, analytical and safety thresholds, medical device materials and ISO 10993-18, custom made mechanisms for different product types.

Join our event to learn innovative techniques for analyzing and testing for extractables and leachables in biopharmaceutical development. This should help you to significantly lower the risks associated with E&L and assure patient safety and product integrity.

WE WILL TALK ABOUT

  • evaluation of extractables and leachables as a vital part in product development and launch
  • precise analytical techniques for E&L compound screening, identification and quantification
  • expert knowledge sharing in the planning, carrying out and reporting of E&L studies
  • analysis of regulatory revisions to maintain compliant and cost efficient regulatory approvals
  • industry standards for chemical characterization and toxicological risk assessment
  • comprehensive E&L evaluations of complex materials, products and processes

WHO IS IT FOR?

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
Principal Scientist
Element Material Technology
Research Materials Engineer
FDA
Senior Associated Scientist
GILEAD SCIENCES
Senior Principal Scientist – Team Leader
USP
Staff Scientist
THERMO FISHER SCIENTIFIC
E&L Manager/Global Leader
SGS Health Science
Scientist
SARTORIUS
Director R&D
MERCK KGaA
Extractables & Leachables Specialist Consulting Services
E.L-XPERT Ltd
Application Scientist
LHASA LIMITED
Manager Material Development
DATWYLER
Sr. Research Scientist
FRESENIUS KABI
Vice President, Informatics
INSTEM
Research Scientist II
BAXTER HEALTHCARE
Global QA for E&L
GSK Vaccines
E&L Global SME
GSK Vaccines
Senior Principal Research Toxicologist
Greg Erexson Toxicology Consulting, LLC
Principal Scientist / Sr. Group Lead
LONZA DPS
Team Lead Corporate Material Qualification
OCTAPHARMA
Director, Senior Expert Nonclinical Safety
BAYER AG
European E&L Strategic Director
BICYCLE THERAPEUTICS
Previous Events

WHO ATTENDED THE EVENT IN 2022

● 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.

MEDIA PARTNERS
Event Details
Sponsors