2022
Speaker – An Industry Perspective on Converting EUAs to De Novos and 510(k)s
Moderator – EU MDR/IVDR Workshop
2022
Speaker – Q-Submissions Best Practices
2021
Panelist – Insights & Experiences from the Implementation of the EU MDR / IVDR & IVDR Compliance – Strategies for Ensuring Your Product Meets Quality & Compliance Requirements
2020
Speaker – EU MDR & IVDR Compliance: Tales from the Trenches
2019
Speaker & Track Moderator & Chair – Regulatory & Quality Update & Evaluating Pre-Market Pathways for US Market
2018
Speaker – MDR & IVDR Overview
2014
Moderator – Regulatory Track Day 1
2021
Speaker – Emergency Use Authorizations (EUAs) – Tales from the Trenches
2021
Speaker – RAC Exam Study Group
2020
Speaker – Emergency Use Authorizations – Tales from the Trenches
Speaker – SDRAN RAC Exam Study Group
2019
Speaker – SDRAN CAN RAC Study Group (2019, 2018, & 2016)
2017
Speaker – US RAC Study Group (2017 & 2016)
Speaker – SDRAN EU RAC Study Group (2017-2014)
2020
Program Chair & Moderator
2019
Program Chair & Moderator
Speaker
2018
Speaker, Program Manager, & Moderator
2017
Program Manager & Moderator
Speaker, Program Manager, & Moderator
2016
Program Moderator & Manager
2015
Program Moderator & Manager
FDA-OCRA Annual Educational Conference – U.S. Pre-Market Submissions – How to file and manage 510(k)s, PMAs, and De Novo applications
2014
Speaker
Program Moderator & Manager
2011
Program Moderator & Manager
2008
Program Moderator & Manager
Speaker
Speaker, Program Manager, & Moderator
2017
Speaker
2014 – Present
Part-Time Instructor
Instructor and re-developer for RA 773 “Medical Device Regulations” course in the Master of Science in Regulatory Affairs program
Guest lecturer for RA 601 “The Pharmaceutical, Biotechnology and Medical Device Industries” on the topics of combination products, introduction to medical devices, pre-market global medical device requirements, and post-market global medical device requirements
Guest lecturer for RA 696 “Drug/Device Product Development and Regulation – Europe and US” on topics of medical device QSR, ISO 13485, and US pre-market submissions
Participate on the Faculty Advisory Board and as a Faculty Advisor for student Capstone projects
2021 – Present
Part-Time Instructor
Developer and instructor for MSPS 620 – “Introduction to Regulatory Affairs” course for the School of Pharmacy
2012 – 2013
2016 – 2021
Part-Time Instructor
Developer and instructor for BIOL 425 “Medical Product Development and Regulatory Affairs: Bench to Bedside” course with a focus on the HCT/P regulations for the Bridges to Stem Cell Research (BSCR) program
Developer and instructor for BIOL 539 “Pre-Market Submission Process” for the Clinical Trial Project Management Certificate Program
Co-developer and co-instructor for BIOL 535 “Regulatory Requirements for Medical Products” for the Clinical Trial Project Management Certificate Program.
2012 – 2013
Part-Time Instructor
Instructor for EECS X445.26 “Regulatory Requirements for Pharmaceutical Products” course
Co-instructor and co-developer for EECS X432.01 “Technical Writing for the Medical Product Industry” course
2015
Guest Lecturer
2008
Guest lecturer
2008
Guest Lecturer
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