1st Pharmaceutical Industry Summit in Japan
 『国際共同治験における各国とのRegulation ~CFDA~』
 講演者:Gao Yang
                  Principal Consultant
                  PAREXEL Consulting - Beijing, China                                


      2005~2013  CMC reviewer at CDE of CFDA
      2013~2017  Eli Lily China RA CMC & Device Head
      2015             Chairman in RDPAC CMC Council
      2017~2018  RA Director in Ascentage Pharm
      2018~          Principal Consultant in PAREXEL
      Ph.D., PKPD, China Pharmaceutical University
      Master, Pharmaceutical Science, China Pharmaceutical University
      Bachelor, Pharmacy, Shandong Medical University
     CMC & BE : profound understanding of both ICH and China regulatory
                         CMC requirements, with rich hands-on experience of 
                         dossier reviewing, gap analysis and problems solving for
                         IND, NDA, ANDA and Supplementary applications.
     General regulatory affairs : comprehensive understanding of China                                                                                                  regulatory system. Hands-on experience 
                                                    to manage the whole process of preparing, 
                                                    submitting and maintaining the regulatory
                                                    applications and documents. Hands-on
                                                    experience to develop a global regulatory
                                                    plan with integrating R&D and business