Webinar on Vaccine Product Overseas Registration Strategy, WHO Prequalification Path Selection and Case Sharing

Date: September 24,2024

Agenda:

10:00-10:10  Welcome Remarks & Introduction of participants, speakers and schedule

10:10-10:35   How to develop the overseas strategy for vaccine products

10:35-10:55   Path selection of WHO prequalification for vaccines

10:55-11:15   Formulation and implementation of Convidecia's registration strategy in Malaysia

11:15-11:30   Online interview&Webinar summary

Speakers introduction：

Dr. Zhao Hailin

Dr. Zhao is an expert in global innovative drug discovery, having built and led functional teams for global registration regulatory affairs at Dong-A Pharmaceuticals and Green Cross.He also led CMG Pharmaceutical's global business unit and invested in Bio-ventures while at TGD Investment. He has extensive experience in the development of natural products, chemical drugs (innovative chemicals, improved new drugs), and biological products (proteins, vaccines, blood derived products, and cell therapies), with a focus on most regions including the United States, the European Union, Japan, China, and Canada. His contributions also included serving as a principal investigator for government-funded projects, receiving excellence awards from the Korea Food and Drug Administration (MFDS), and serving as an external consultant to MFDS and as an reviewer for government-funded biological projects. He is currently the Chief Research Officer of Eyegene, Inc.

Ms. Tracy WANG

Tracy Wang worked in regulatory affairs for all sorts of medical products, including diagnostics, vaccines, therapeutical biologics, and small molecules for more than 20 years. Ms. Wang has rich experience in formulating drug development strategy and registration strategy, pre-IND, IND, BLA, NDA, different kinds of regulatory authority meetings, domestic and oversea GCP and GMP inspections, WHO prequalification and so on. She is the owner and president of VitaProsFan Health Solution Inc., Canada. She previously served as Senior Vice President at Clover Biopharmaceuticals Ltd., a domestic innovative pharmaceutical company, and was responsible for regulatory affairs and government affairs in China. Before that she joined in Xuanzhu Biopharm as Head of regulatory affairs, global leading CRO Parexel as Head of China regulatory affairs, MSD R&D (China) center as Associate Director in charge of vaccine and women’s health therapeutical areas. And she also worked in the department of regulatory affairs of Shanghai Novartis Trading Ltd. and Shenzhen Sanofi Pasteur Biological Products Co., Ltd. for multiple years. Tracy Wang received her MBA from Renmin University of China and a bachelor’s degree from China Pharmaceutical University.

Ms. Jiang Rong

Graduated from Huazhong Agricultural University, she is currently the Director of International Registration Department of CanSino Biologics Inc., with 11 years of experience in vaccine concept proof, process development, international clinical trial application and international new drug registration application.During working in the International Registration Department of CanSino, She was responsible for overseas clinical application of recombinant COVID-19 vaccine, quadrivalent meningococcal polysaccharide conjugate vaccine, recombinant herpes zoster vaccine, recombinant poliomyelitis vaccine,etc., and obtained multiple clinical approvals.Responsible for the registration and application of recombinant COVID-19 vaccine in many overseas countries and regions and WHO EUL new drug,obtained more than 10 approvals; and responsible for other products in overseas new drug application.

Original links：https://mp.weixin.qq.com/s/NUI12td_XsTCeulCnjHObg