May 19th – May 20th 2021
Extractables and leachables (E&L) studies has now become a key component of product launch. Regulatory agencies are very concerned about the interaction between the final drug product and container closure systems, drug delivery devices, as well manufacturing components. Hence, the migration of mobile chemicals from components and ingredients used in drug production and storage demands careful evaluation.
Our dedicated online meeting brings together managers, scientists and toxicologists in the E&L field to share the latest in analytical methods for E&L, regulatory updates and compliance, risk based E&L programs, chemical characterization, toxicological risk assessment, E&L studies validation, E&L assessment in biomanufacturing and processing equipment, E&L data for selection and qualification of single use systems, material selection/screening/qualification, custom approaches for the specific type of product.
Be present at our virtual meeting to equip yourself with new tools and vital knowledge to analyse and test for extractables and leachables in biopharmaceutical development to effectively minimize E&L associated risks and assure patients’ safety and product quality.
WE WILL TALK ABOUT
- extractables and leachables studies as a critical component of product development and release
- accurate analytical methods to screen, identify and quantify extractable and leachable compounds
- hands on experience from pharma experts on designing, carrying out and reporting of E&L studies
- reviewing recent regulatory updates, ensuring compliance and cost-effective regulatory approvals
- best practices for material and chemical characterization and toxicological risk assessment of E&L
- comprehensive and compliant E&L assessment for complex materials, products and processes
WHO IS IT FOR?
CxO, VP, 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
White Paper | Extractables and Leachables Strategies for Pharmaceutical Production Tubing
White Paper | Extractables and Leachables Strategies for Transdermal Delivery Patch Products
Case Study | Extractables Study of Bioprocessing Single-Use System
White Paper | Extractables and Leachables Strategies for Prefilled Syringes
WHO ATTENDED THE EVENT
● 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