4th Annual Extractables & Leachables Conference

4th-5th of December 2023,  Prague

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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, 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.

Key points

  • 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

Gold Sponsor

OUR PARTNERS

Contact Us

BECOME A SPEAKER

Daria Pavlovska
Conference Producer
Tel.: +420 228 227 163
E-mail: daria.pavlovskaya@bcf-events.com

BECOME A DELEGATE

Valerie Neumann
Senior Marketing Manager
Tel.: +420 228 227 162
E-mail: valerie.neumann@bcfgroup.eu

BECOME A SPONSOR

Daria Novoseltseva
Business Development Manager
Tel.: +420 228 227 163
E-mail: daria.novoseltseva@bcf-events.com