March 30th – March 31st 2022
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