2nd Annual Extractables & Leachables Summit 2022

March 30^th – March 31^st  2022

VIRTUAL CONFERENCE

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

• 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?

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

WHO ATTENDED THE 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 ● Niutec AG ● Norbrook Laboratories Ltd ● Norner AS ● Novartis Pharma AG ● Octapharma AB ● Par Pharmaceutical ● Pharma Mar ● Pliva Croatia Ltd. ● PLIVA Hrvatska d.o.o. ● QUINTA-ANALYTICA 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 ● Xellia d.o.o.