Patient-Centric Regulatory Affairs & Policy
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About

Dr. Carrie M. Kuehn

 

Improving patient lives by providing expertise in patient engagement, FDA regulatory affairs, and advocacy for patient-centric regulatory policy.

 
 

Thank you for your interest in my consulting work! I am passionate about attacking complex problems where medicine, public health, and law intersect. I have a diverse background and over 20 years of experience in epidemiology, medicine, FDA regulatory affairs and patient-focused policy. My training and education give me a strong foundation in science, medicine, statistics, law, and policy. In practice, I have applied my skills and expertise to the conduct of observational research, the application of FDA regulatory affairs to the medical products industry, and the development of, and advocacy for, patient engagement regulatory policy.

I am valued for my ability to simplify complex, multidisciplinary problems into a cohesive strategy that leads to efficient solutions. I am an accomplished researcher with exceptional written communication skills, having published in the areas of public health, regulatory affairs, and patient engagement policy. In adversarial situations, I have provided medical device sponsors and their defense counsel with consulting and testifying expert testimony in state and federal court in support of litigation as a FDA regulatory expert.

As part-time faculty with the College of Professional Studies at Northeastern University’s Regulatory Affairs Graduate program, I have the privilege of preparing the next generation of patient-focused regulatory professionals.

Contact me to determine how I can best apply my adaptable skill set to address the complex issues you may be facing in your efforts to improve patient lives around the world.

You can find a copy of my curriculum vitae here. I look forward hearing from you!

Dr. Carrie M. Kuehn, Principal Consultant

Dr. Carrie M. Kuehn, Principal Consultant


Credentials

Doctor of Law and Policy

Dissertation: Role of Patient Advocacy Stakeholders in Science‐based Regulatory Policy at the U.S. Food and Drug Administration (FDA). Boston, MA, Northeastern University, College of Professional Studies

Regulatory Affairs Certified (RAC), U.S. Medical Device and Pharmaceutical Regulatory Affairs (2011-2019)

Certificate in U.S. Pharmaceutical & Medical Device Regulatory Affairs. Rockville, MD. Regulatory Affairs Professional Society (RAPS)

Master of Public Health, Epidemiology

Thesis: Birth Malformations and Residential Proximity to Hazardous Waste Sites in Washington State. Seattle, WA, University of Washington, School of Public Health

Master of Arts, Biocultural Anthropology

Thesis: Dermatoglyphic Asymmetry and Handedness in Individuals Exposed to Alcohol Prenatally. Seattle, WA, University of Washington, Department of Anthropology

Bachelor of Arts, Anthropology

Seattle, WA, University of Washington, Department of Anthropology

 
 

Selected Publications

Marsh K, Hawkin N, Brookes E, Kuehn C, Liden B.  Patient-centered benefit-risk analysis of transcatheter aortic valve replacement. F1000Research. 8(394. May 20, 2019

Kuehn, CM and Selig, WKD.  Literature Review:  Patient Engagement in Clinical Trials.  A Report of the Science of Patient Input Program of the Medical Device Innovation Consortium (MDIC).  March 29, 2019.

Kuehn, CM. Patient Experience Data in US Food and Drug Administration (FDA) Regulatory Decision Making: A Policy Process Perspective. Therapeutic Innovation and Regulatory Science. Sep 2018; 52(5):  661 – 668.

Kuehn, CM, Bockmuller, T. Considerations for Discovery in Medical Device Litigation. Rx for the Defense. DRI Newsletter of the Drug and Medical Device Committee 2015: 23(4). 6‐8.

Glezen WP, Schmier JK, Kuehn CM, Ryan KJ, Oxford J. The burden of Influenza B: A structured literature review. American Journal of Public Health March 2013; 103(3): e43‐e51.

Yorkston KM, Kuehn CM, Johnson KL, Ehde DM, Jensen MP, Amtmann D. Measuring participation in multiple sclerosis: A comparison of the domains of frequency, importance, and self‐efficacy. Disab Rehab 2008; 30(2):88‐97.

Cetin K, Johnson KL, Ehde DM, Kuehn CM, Amtmann D, Kraft GH. Antidepressant use in multiple sclerosis: Epidemiologic study of a large community sample. Multiple Sclerosis 2007; 13(8):1046‐1053.

Jensen MP, Kuehn CM, Amtmann D, Cardenas DD. Symptom burden in persons with spinal cord injury. Arch Phys Med Rehab 2007; 88(5):638‐645.

Johnson KL, Dudgeon B, Kuehn CM, Walker W. Assistive technology use among adolescents and young adults with spina bifida. Am J Pub Health 2007; 97(2):330‐336.

Kuehn CM, Mueller BA, Checkoway H, Swanson M. Risk of malformations associated with residential proximity to hazardous waste sites in Washington State. Environ Res 2007; 103(3):405‐412.

Mueller BA, Kuehn CM, Shapiro‐Mendoza CK, Tomashek KM. Fetal deaths and proximity to hazardous waste sites in Washington State. Environ Health Perspect 2007; 115(5):776‐780.

Johnson KL, Kuehn CM, Yorkston KM, Kraft GH, Klasner E, Amtmann D. Patient perspectives on disease‐ modifying therapy in multiple sclerosis. Int J MS Care 2006; 8(1):11‐18.

Podvin D, Kuehn CM, Mueller BA, Williams M. Maternal and birth characteristics in relation to childhood leukemia. Paediatric Perinatal Epidemiol 2006; 20(4):312‐322.

Johnson KL, Amtmann D, Yorkston KM, Klasner ER, Kuehn CM. Medical, psychological, social and programmatic barriers to employment for people with multiple sclerosis: A review of the literature. J Rehab 2004; 70.

Johnson KL, Yorkston KM, Klasner ER, Kuehn CM, Amtmann D. The cost and benefits of employment: A qualitative study of experiences in individuals with multiple sclerosis. Arch Phys Med Rehab 2004; 85:201‐209.

Yorkston KM, Johnson KL, Klasner ER, Amtmann D, Kuehn CM. Getting the work done: A qualitative study of individuals with multiple sclerosis. Disab Rehab 2003; 25(8):3690‐379.

Book Chapters

Ochoa JA, Siskey R, Kuehn CM, Ciccarelli L. Medical device regulation and retrieval analysis. In: Beyond the Implant:  Retrieval Analysis Methods for Implant Surveillance. Ed. William M. Mihalko, Jack Lemons, Seth Greenwald, and Steven M Kurtz. 2018.

Kuehn CM. and Yardimci A. Best Practices for Documenting Objective Evidence of Verification & Validation.  In: The Medical Device Validation Handbook. Ed. Roberta Goode. 2018

Kuehn CM, Jennings J. Chapter 7. Current good manufacturing practices & quality system design. In: US Fundamentals of Regulatory Affairs, Tenth Edition, 2017.

Kuehn CM, Jennings J. Chapter 10. Current good manufacturing practices & quality system design. In: US Fundamentals of Regulatory Affairs, Ninth Edition, 2015.

Kuehn CM, Siskey R. Good manufacturing and laboratory practice for medical device development (cGMP and cGLP). Ch. 3‐9. In: Bringing Your Medical Device to Market, 3rd Edition. Reiss JB (ed), FDLI, 2013.

Weiler (Kuehn) CM, Taylor KM. Forensic anthropology. pp. 179‐189. In: Forensic Medicine Sourcebook. Muth AS (ed.), Omnigraphics, Detroit, MI 1999.