Strategic Biopharma Regulatory Approaches for China

May 21, 2019 8:00 AM - 10:00 AM

MassBio, 300 Technology Square 8th Fl, Cambridge, MA 02139

Add to Calendar 5/21/2019 8:00:00 AM 5/21/2019 10:00:00 AM Strategic Biopharma Regulatory Approaches for China China is the second largest biopharmaceutical market in the world, just behind the US. Its demand for medicines is growing fast and the government has been aggressive in implementing change. Therefore the Chinese market is becoming increasingly more of a strategic priority for foreign companies. Fast changing regulatory reforms by the CDA aim to accelerate the regulatory review process so new products can be launched to meet patient’s needs. This forum will provide the latest updates on Chinese regulatory policy reform for the biopharma regulatory professional. Our panel will share their experiences and suggest strategic approaches to optimize your company’s regulatory strategies and pathways in China. Coverage will include: CDAs approach to rare diseases and accelerated pathways; new things to know about the CTA application, NDA/BLA and much more. MassBio, 300 Technology Square 8th Fl, Cambridge, MA 02139

Head of Strategy and IR, Beigene

Lucy Li, PhD, is Head of Corporate Strategy at BeiGene, a global, commercial-stage, research-based biotechnology company focused on molecularly targeted and immuno-oncology cancer therapeutics. Lucy joined BeiGene in 2015, which IPO'd on the Nasdaq in 2016 and listed on the Hong Kong exchange in 2018. Prior to BeiGene, Lucy spent several years working as a strategy consultant to the life sciences industry. She holds a PhD in Neurology and Neurosciences from Washington University in St. Louis and a BS in Biological Sciences from Peking University.