Ahead of her presentation at the inaugural Extractables and Leachables China this September, we spoke to Lynn Yao, Scientific Affairs Manager at West Pharmaceutical Packaging (China) to discuss the escalating stringency in the regulatory requirements for E&L, why it's important to be involved in this event, future significant changes in the market and much more.
Q. You are speaking on an overview of E&L study in China due to an escalating stringency in the regulatory requirements, why do you feel this is an important topic for the industry?
E&Ls always cause attention due to their potential compatibility risk for the drug product, hence safety risk to patients. And there is no surprise that pharmaceutical companies and agencies in China are interested. As a result, the request for E&L data is raised on dossier submissions so it's important to understand the regulatory requirements in China.
Q2. Why do you feel it's important to be involved in an event looking at E&L regulations in China?
Since E&L study is growing in importance in China, I think this conference provides a good opportunity for the audience to capture the trends of E&L study and understand the regulations for China.
Q3. What do you think are the most significant changes taking place in the Chinese market in the coming 12-18 months?
The Chinese pharmaceutical industry is under a series of reforms with the aim of encouraging innovation and reducing the backlog of registration applications, which will also help to upgrade the drug products standards up to international standards.
Q4. What are you most looking forward to at the event?
I'm looking forward to the training session and the updates about different regulations in the world.
Lynn will be presenting as part of the 'Enabling Science in E&L' session on day two of the conference. Other speakers at the event include Suzhou Baxter R&D, Waters Technologies, Beijing University of Chemical Technology, Smithers Rapra, NIBRT, CNPPA and more.
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