ABOUT CONFERENCE
We are delighted to invite you to the 4th Annual Extractables & Leachables Conference, which will take place on the 4th – 5th of December, 2023 in Prague, Czechia.
The 4th Annual Extractables & Leachables Conference will bring scientists, toxicologists and E&L managers to discuss the most recent analytical strategies, regulatory updates, and risk-based E&L programs, chemical characterization and toxicological risk assessment, analytical and safety thresholds, medical device materials and ISO 10993-18, custom-made mechanisms for different product types.
The conference covers the regulatory landscape, advances in science and testing methods, the latest technological developments, biocompatibility, biomanufacturing, BPOG vs. USP, as well as featuring case studies from leading experts in the field.
The 2 Days of the conference will include Q&A sessions as well as a panel discussion, round tables with some of the keynote speakers, an opportunity to communicate in formal and informal atmosphere.
- Biopharmaceutical Products: Monitoring of antioxidant additives in single-use systems; Clearance of
Bioprocess Equipment Leachable; Single-Use Technology - Analytical Chemistry: Screening Methods; High Resolution Mass Spectrometry Technology Usage; Managing Unknown Compounds
- Medical Devices: TTC Application; AET Establishing
Considerations; Challenges with E&L
- Toxicology: Duration-Based Non-Mutagenic Thresholds of TTC; EMA Guideline on Genotoxic Impurities; Toxicological Risk Assessment
- Regulations, Standards: ISO 10993-18; Plastic Manufacturing Components Standard; The BPOG protocol; FDA Guidance
- Materials: Evaluations of Complex Materials, Products & Processes; Pharmaceutical Rubber; Silicone Components
SPEAKERS
Contact Us
BECOME A SPEAKER

E-mail: daria.pavlovskaya@bcf-events.com
BECOME A DELEGATE

E-mail: valerie.neumann@bcfgroup.eu
BECOME A SPONSOR

E-mail: daria.novoseltseva@bcf-events.com