2nd Annual Extractables & Leachables Summit 2022

March 30^th – March 31^st2022

VIRTUAL CONFERENCE

CONFERENCE OVERVIEW

CONFERENCE OVERVIEW

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.

WE WILL TALK ABOUT

WE WILL TALK ABOUT

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

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

BECOME A SPONSOR

SPEAKER SPONSOR

Speaking Companies

Speaker Board

BECOME A SPEAKER

Paolo Grisostomi

Sr. Engineer, Materials Science

Biogen

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

Regeneron

Diane Paskiet

Director – Scientific Affairs

West Pharma

Roberto Menzel

Head of Extractables Laboratory

Sartorius

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

AstraZeneca

[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.

REQUEST BROCHURE

Previous Event

Expired

[•REC] - €350

Extractables & Leachables for Pharma Summit 2021

Pharma

May 19, 2021

Online

ATTENDEES IN 2022
ATTENDEES IN 2021

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