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
Vice President, APAC, PAREXEL
Dr. Chang Lee is Vice President of Consulting, APAC: Dr. Lee brings both industry and regulatory agency experience to PAREXEL. He led Regulatory and Clinical Affairs at Capsugel, KV Pharmaceuticals, Morton Grove Pharmaceuticals, TAP Pharmaceutical Products Inc., Novartis OTC, and Igenix, and served as a Medical Officer at the FDA’s Center for Drug Evaluation. U.S. board-certified in Clinical Pathology, he is knowledgeable in global clinical and regulatory product development, including risk management, and has worked with many global regulatory authorities, including FDA, EMA, the Medicines and Healthcare products Regulatory Agency (MHRA), Health Canada, the Central Drugs Standard Control Organization (CDSCO) in India, and the China Food and Drug Administration (CFDA). Chang received his M.D. from Xian Jiaotong University Medical College (formerly Xian Medical University) in Xian, China. Dr. Lee later went to the University of Alabama at Birmingham where he received his M.S. in Health Services Administration and then his Doctor of Public Health. Dr. Lee did his residency in Pathology at the University of Chicago, is Board-Certified in Clinical Pathology American Board of Pathology, and Fellow of American College of Pathologist.