3rd Annual Extractables & Leachables Summit 2023 - uventia

3rd Annual Extractables & Leachables Summit 2023

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March 9th – March 10th  2023

VIRTUAL CONFERENCE

CONFERENCE OVERVIEW

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

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?

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
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Speaking Companies
Speaker Board
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Nick Morley
Principal Scientist
Element Material Technology
David Saylor
Research Materials Engineer
FDA
Melisa Masuda-Herrera
Senior Associated Scientist
GILEAD SCIENCES
G. Prabhakar Reddy
Senior Principal Scientist – Team Leader
USP
Weifeng Lin
Staff Scientist
THERMO FISHER SCIENTIFIC
Dujuan Lu
E&L Manager/Global Leader
SGS Health Science
Tanja Verena Maier
Scientist
SARTORIUS
Markus Obkircher
Director R&D
MERCK KGaA
Graham Wilson
Extractables & Leachables Specialist Consulting Services
E.L-XPERT Ltd
Charlie Modlin
Application Scientist
LHASA LIMITED
Tine Hardeman
Manager Material Development
DATWYLER
Jianfeng Hong
Sr. Research Scientist
FRESENIUS KABI
Glenn J. Myatt
Vice President, Informatics
INSTEM
Steve Zdravkovic
Research Scientist II
BAXTER HEALTHCARE
Etienne Michel
Global QA for E&L
GSK Vaccines
Marine Lepoutre
E&L Global SME
GSK Vaccines
Dr. Greg Erexson
Senior Principal Research Toxicologist
Greg Erexson Toxicology Consulting, LLC
Dr. Lukas Mogler
Principal Scientist / Sr. Group Lead
LONZA DPS
Alicja Sobańtka
Team Lead Corporate Material Qualification
OCTAPHARMA
Dr. Clemens Günther
Director, Senior Expert Nonclinical Safety
BAYER AG
Dr. Andrew Feilden
European E&L Strategic Director
BICYCLE THERAPEUTICS

[Agenda] 3rd Annual Extractables & Leachables Summit 2023

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

REQUEST BROCHURE
Previous Events
Expired
2nd Annual Extractables & Leachables Summit 2022
March 30, 2022
Expired
Extractables & Leachables for Pharma Summit 2021
May 19, 2021

ATTENDEES IN 2023

● 3M ● Albhades ● ALK-Abelló S.A. ● Analytical Expertise Center, MoH of Azerbaijan Republic ● Antibiotice SA ● AstraZeneca ● B. Braun Medical Industries Sdn. Bhd ● B. Braun Medical SA ● Bausch Health ● Baxter Healthcare ● Bayer AG ● BD ● Bicycle Therapeutics ● BioConnection BV ● Biogen ● Brainfarma Industria Quimica e Farmacêutica S.A. ● Chorley Consulting Ltd ● CleanControlling Medical GmbH & Co. KG ● CSL Behring ● Datwyler ● Donaldson ● Donaldson BV ● Dr. Anika Schroeter e.U. ● DuPont ● E.L-Xpert Ltd ● Element Material Technology ● ELSIE Consortium ● EQUITOX ● Fastnet Biopharma ● Fischer PreclinTox Consulting ● Fresenius Kabi ● Gateway Analytical ● GBA Pharma GmbH ● GE HealthCare ● Gilead Sciences ● Gilead Sciences, Inc. ● Greg Erexson Toxicology Consulting ● GSK ● ICU Medical ● Incyte ● Instem ● Intertek Schweiz AG ● Johnson & Johnson ● Laboratorios Normon SA ● LACER, S.A.U ● Lhasa Limited ● Lonza ● Lonza Drug Product Services ● Made Consulting Ltd Oy ● Mallinckrodt Pharmaceuticals ● Merck Group ● Merck KGaA ● Neotron Spa ● Octapharma ● Padagis Israel Pharmaceuticals ● Pharmaceutical Firm Darnitsa ● PHOX Consulting e.U. ● Polpharma Biologics S.A. ● PolyCine GmbH ● Promega Corp ● Quinta-Analytica, s.r.o. ● Safetree Consulting e.U. ● Sartorius ● SCC Scientific Consulting GMBH ● SEPTODONT ● SGS Health Science ● Sun Pharmaceutical Industries Ltd. ● Terumo Blood and Cell Technologies ● Teva Pharmaceuticals ● Teva Pharmaceuticals Ireland ● Therapeutic Goods Administration ● Thermo Fisher Scientific ● Tofwerk AG ● U.S. Pharmacopeia ● United States Pharmacopeia ● Universidade de São Paulo ● US Food and Drug Administration ● Waldemar Link ● Westlake ● Wonderboom, Inc. ● WuXi AppTec

ATTENDEES 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.

ATTENDEES IN 2021

● 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

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