March 9th – March 10th 2023
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
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.