Lillian Li has 11 years of experience in the IVD industry, with the majority of those years focused on IVD registration (including clinical trials). She also spent one (1) year as a Clinical Research Associate (CRA) in the pharmaceutical industry. Lillian has extensive experience in successfully transferring IVD manufacturing lines from Europe to China. She also has a strong understanding of Chinese IVD regulations and supporting registration strategy for imported and local products.

Lillian received her Bachelor Degree in Biochemistry from the China Pharmaceutical University (Nanjing, China) and a Master Degree in Microbiology from Third Institute of Oceanography of the Ministry of Natural Resources (Xiamen, China). Her research project during her Master Degree program focused on isolating one novel chemical structure from Streptomyces Albogriseolus and is published in Molecules.

CORE COMPETENCIES

• Making strategic registrations with IVD products, aggressively shortening timelines to certify and launch products into market
• Launching IVD products into the Chinese market by providing support with the global strategy for registration, developing guidelines for feasibility studies and validation studies, working with Quality Management Systems (QMS) for sampling, quality control (QC) type testing, following technical review and obtaining the license
• Managing multiple types of registration modifications, including raw material modifications and supplier modifications
• National Medical Products Administration (NMPA) registrations
• Preparing design dossiers and technical files, including preparation and input into key documents/General Safety and Performance Requirements (GSPR) checklists, risk management documentation, study reports and performance evaluation documentation
• Interpreting and implementing Medical Device Coordination Group (MDCG) guidance documents

RECENT PROJECTS

• In Vitro Diagnostic Regulation (IVDR) multi-geographic regulatory assessment project, addressing weaknesses in the technical documentation and developing technical documentation for the NMPA/IVDR submission
• Worked as a project leader to oversee NMPA projects including typing testing, clinical trial and NMPA submission
• Created a strategic China marketing plan
• Provided regulatory support for a project involving a high-risk level of class III IVD