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SDRAN: Emergency Use Authorizations – Tales from the Trenches
July 15 @ 6:00 pm - 7:30 pm
Emergency Use Authorizations – Tales from the Trenches
Kim Walker Consulting
DATE: Wednesday, 15 July 2020
TIME: 6:00 – 6:05 PM Welcome and Announcements (ONLINE)
6:05 – 7:05 PM Program Presentation (ONLINE)
7:05 – 7:30 PM Q & A (ONLINE)
LOCATION: Not applicable – This is an ONLINE event
Click here to register for this event.
Please join us for an overview of what Emergency Use Authorizations (EUAs) are, how to
submit one, and recent experiences from those who have filed COVID-19 related EUAs.
Wednesday, 15 July 2020
Kim Walker, MS, RAC, FRAPS is an independent Global Regulatory Affairs, Quality Assurance,
and Clinical Affairs Consultant and owner of Kim Walker Consulting since 2006. In her consulting
practice, she assists clients with pre- and post-market regulatory, clinical, and quality system
needs. Her work experience includes environmental chemistry, veterinary science, blood
banking, clinical laboratory science, infectious disease assay research, microbiology, surgical
assistant, IVDs, biologics, pharmaceuticals, combination products, and medical devices in
university, start-up company, and large company environments. Kim has served on the Orange
County Regulatory Affairs Discussion Group (OCRA) Program Committee since 2003.
Additionally, she served on the OCRA Board of Directors (BOD) 2004-2010 and 2019 and was
the 2008-2009 President. Kim participated on the CLSI Point of Care Testing, Quality Systems,
EP9, and Process Improvement working groups and was listed as one of the authors for CLSI
GP22-A3. Quality Management System: Continual Improvement. She has managed, presented
at and/or moderated at several professional conferences and educational institutions on clinical,
regulatory, and quality topics. She also has participated in the SDRAN Mentoring Program since
2009. Kim participated on the CSUPERB Advisory Committee and Development Team for the
Project Management in Clinical Trials certificate program through California State University,
Fullerton (CSUF). She was the instructor for the “Pre-Market Submission” course and coinstructor for the “Regulatory Requirements for Medical Products” course in the certificate
program. Kim was also an instructor for the “Regulatory Requirements for Pharmaceutical
Products” course and a co-instructor for the “Technical Writing for the Medical Product Industry”
course at the University of California Irvine Extension. She also re-developed and currently
teaches the “Medical Device Regulations” course for the SDSU Master of Science in Regulatory
Affairs program. Kim developed and has taught since 2016 an undergraduate “Medical Product
Regulations: Bench to Bedside” course at CSUF with a focus on stem cell therapies. She achieved
both the US and EU RAPS Regulatory Affairs Certifications and has been accepted as a RAPS
Fellow in recognition of her contributions and leadership in advancing the regulatory profession.
Additionally, Kim received the 2008 Leonard Stauffer Award from RAPS in recognition of her
contributions to mentoring and furthering regulatory professional education development. She
has a Bachelor of Science degree in Biomedical Sciences and a Master of Science degree in
Online registration ends Tuesday, 14 July 2020.
$10.00 SDRAN Member $10.00 Non-Member
For Questions Email: [email protected]