SAPA-MDDC 2023  Webinar

“Overview of FDA Regulation of In Vitro Diagnostics and Companion Diagnostics”

This seminar will cover FDA structure, IVD classification, types of submissions, device validation, the unique features of CDx development, as well as recent FDA initiatives to modernize regulations. In addition, the differences between IVDs and LDTs (laboratory developed tests) will be discussed.

Time: 8:00-9:30 pm, June 21, 2023

Location: Zoom Meeting

Register Here

Speaker Bio:

Zhijun (Julie) Pan, M.D., Ph.D., RAC, Senior Director, Global Regulatory Leader IVD at Bayer Oncology leading IVD regulatory affairs for precision medicine. She previously held regulatory affairs roles at Leica Biosystems, Bayer Radiology, Bayer Diabetes Care, and Siemens Healthcare Diagnostics.

Dr. Pan has over 16 years of regulatory affairs experience in IVD, medical device software, and pharmaceuticals. Prior to her industry career in regulatory affairs, Dr. Pan was a physician scientist specializing in gastroenterology with extensive research experience in Helicobacter pylori, including developing diagnostic assays for diagnosis of H. pylori infection and related GI diseases.

Dr. Pan holds a BS in Medicine from Xinjiang Medical College, a masters and a doctorate degree in gastroenterology from Shanghai Second Medical University, and a Ph.D. in molecular microbiology from the University of Amsterdam. She completed her postdoctoral research at Washington University School of Medicine in St. Louis.

SAPA-MDDC Community:

SAPA-MDDC (Medical Device & Diagnostics Community) has been established since February 2022.

Our Mission is to: (1) build a community for sharing ideals, knowledge and passion in the field of medical device and diagnostics; (2) provide networking opportunities and stimulate collaborations among medical device professionals; (3) bring learning opportunities and industry prosperity in medical device to young professionals.