Chikako Kitayama is a Diplomate of American Board of Toxicology (DABT) based out of NAMSA’s Japan office. She has been in the industry for over 16 years, joining NAMSA in 2016 working in regulatory affairs, and then moving on to biological safety in 2017. Her current role involves preparing biological safety evaluations, toxicological risk assessments, and changing control assessment reports for medical devices in a wide range of therapeutic areas, including dental devices. She is also responsible for reviewing biological safety reports for Japanese Pharmaceutical and Medical Device Agency (PMDA) submissions. Prior to NAMSA, Chikako worked for a Japanese Contract Research Organization (CRO) as a regulatory affairs specialist focused on PMDA submissions for broad areas of medical devices, such as cardiovascular, orthopedics, wound care, and ophthalmic devices.

She graduated Nagoya University and obtained her master’s degree and Ph.D. in Molecular Cellular Biology from the University of Tokyo. She has experience as a scientific researcher at the National Institute of Advanced Industrial Science and Technology and Tsukuba University in Japan.

CORE COMPETENCIES

• Preparing risk assessments, evaluation plans, and reports in compliance with ISO 10993-1, ISO 10993-17, and ISO 14971 for submissions to the FDA and other regulatory agencies
• Evaluating and summarizing biocompatibility and general toxicology data, ensuring compliance with the relevant regulatory requirements and standards
• Working knowledge of medical device regulations and/or biologics regulations, ISO 10993 series and ISO 14971
• Ensuring biocompatibility studies are compliant with most recent regulatory requirements
• Providing technical support to lab staff
• Advising clients on technical issues related to biocompatibility and material characterization
• Performing biocompatibility gap analyses and writing clear, concise reports
• Performing and summarizing literature searches according the ISO 10993-1 Annex C and any other applicable guidance
• Evaluating and interpreting standard requirements for clients
• Summarizing testing reports for submissions
• Evaluating and determining biological relevance of unexpected results
• Writing interpretations of standards, test methodology, and annotated bibliographies

RECENT PROJECTS

• Prepared deficiency responses to the FDA for a medical device component of a biologic product IND approval.
• Biological risk assessment including toxicological evaluation of chemical data for hemodialyzers for EU submissions.
• Reviewed numerous biological risk assessment reports for PMDA submissions.