Smithers Rapra's Extractables & Leachables China to Feature Leading Experts

Smithers Rapra's popular Extractables and Leachables (E&L) China conference returns this September to Shanghai and is set to be another must-attend event for the industry.

With extractables and leachables growing in importance in China, understanding the regulatory landscape, testing methods, guidelines and best practices for carrying out E&L studies is extremely important to ensure consumer safety and eliminate risk.

As China's only two-day conference dedicated solely to extractables and leachables, E&L China will equip those working within or planning to work within this evolving market with the information they need to succeed. Local stakeholders and renowned experts will gather for two days of training, learning, discussions and networking. Over 100 E&L professionals were in attendance at the 2018 event, so you can be sure that this is the place to be for anyone working within this sector.

The programme will again cover all the most pertinent E&L issues including the regulatory landscape, analytical challenges in E&L, medical devices, biological safety and risk and more. Presentations include:

Alignment of regulations and their impact on E&L assessment – Novo Nordisk, Triad Scientific Solutions, Beijing University of Chemical Technology and Smithers Rapra

Analysis of leachable substances for medical biomaterials – CFDA Hangzhou Medical Device Testing Center

Challenges of E&L study under changing regulatory environment – Lynn Yao, West Pharmaceutical Packaging (China)

Evaluation strategy for comparability of container closure system – Fangfang Zhang, Shanghai Food and Drug Packaging Material Control Center

E&L study for pre-filled syringe – Kathy Huang, Becton Dickinson

How to perform safety assessment of parenteral drug products via appropriate experimental design: Exhaustive extraction vs. simulation extraction – Xiaoxia Ye, Kun Pharmaceutical

Chemical characterisation of acrylonitrile butadiene styrene 3D printed medical devices – Keaton S. Nahan, U.S. FDA

How to properly design and execute extractables assessment on print foil – Weichun Yang, Baxter

Whatever your level or position, E&L China is an important event for anyone currently working within, and those potentially entering this sector.

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