Pharmaceutical Regulation Expert Witness

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This page contains pharmaceutical regulation expert witnesses who testify, consult and provide litigation support on pharmaceutical regulation and related issues. Pharmaceutical regulation expert witnesses and consultants on this page may form expert opinions, draft expert witness reports, provide expert witness testimony at deposition and/or trial as or serve as consulting (non-testifying) experts. The issues and subjects these pharmaceutical regulation expert witnesses testify regarding may include: Accreditation, Antibiotics, Anticoagulation, Biologics Safety Fda, Board Of Pharmacy Relations, C. Difficile, Clinical Trials, Community Pharmacy, Compliance, Critical Point Training, Decubitus Ulcers, Drug Development, Drug Interactions, Drug Safety/Fda, and Drug/Biologics Safety/Labeling/Post Marketing Surveillance.

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Dennis K McAllister, R.PH, FASHP McAllisteRx Consulting LLC

Phoenix, Arizona
Pharmacist, Pharmaceutical Regulation - Pharmacy standard of care/negligence, Board of Pharmacy relations, national pharmacy regulatory affairs, hospital pharmacy, community pharmacy, mail service, non-resident pharmacy issues, pharmacy technology regulations, and automation issues.
Dennis is an Arizona-based pharmacist with a broad set of practice experiences acquired over 40 years of pharmacy practice. He served in the United States Air Force as a pharmacy officer, and opened and operated a community pharmacy after leaving active duty. Dennis has served as Director of Pharmacy at three hospitals, two in rural areas, and the other, an 800-bed facility with an attached children’s hospital in an urban setting. Dennis was a founding faculty member at the Midwestern University College of Pharmacy-Glendale, eventually serving as its Assistant Dean. As the Pharmacist in Charge of the Humana Mail Pharmacy in Phoenix, managing pharmacy practice for a staff of 700 that filled over 35,000 prescriptions each day. Dennis has worked for the last decade as the Senior Director of Pharmacy Regulatory Affairs for Express Scripts, supervising a team that covered all 50 state boards. He recently retired from that position. Dennis has extensive experience in standard of care an...

David B Ross, MD, PhD, MBI

Baltimore, Maryland
Pharmaceutical Regulation, Infectious Diseases - Food and Drug Administration (FDA), drug/biologics safety/labeling/post-marketing surveillance, FDA drug/biologics regulations/procedures/applications (INDs/NDAs/BLAs), clinical trials, drug development, pharmacy compounding, HIV, MRSA, antibiotics, hepatitis, osteomyelitis, influenza, C. difficile
Dr. Ross is a Yale fellowship-trained, board-certified infectious disease physician. An active clinician in practice for over 25 years, he provides patient care in the areas of infectious disease and primary care. Dr. Ross holds a medical degree from New York University School of Medicine, and an undergraduate degree in Molecular Biophysics and Biochemistry from Yale University. He completed his internal medicine residency training at NYU Medical Center, and infectious disease fellowship training at Yale University. Dr. Ross also holds a M.S. and Ph.D. in Biochemistry from NYU, and a Master’s Degree in Biomedical Informatics from Oregon Health and Sciences University. Dr. Ross spent 10 years with the FDA’s Center of Drug Evaluation and Review (CDER) as a medical officer, senior medical reviewer, medical team leader, and new drug review office management official. He has extremely broad experience with FDA regulatory submissions (INDs, NDAs, BLAs, post-marketing safety, labeling ...

Joshua Sharlin, PhD SHARLIN CONSULTING

STEVENSVILLE, Maryland
Pharmaceutical Regulation, Medical Devices - FDA, FDA expert FDA Compliance, FDA Regulations, FDA MAUDE , FDA Drug Safety, FDA Warnings, FDA Drug Warnings FDA Medical Device expert, FDA law, FDA regulatory, Drug Safety/FDA, FDA Medical Devices, Biologics Safety FDA, Implant Safety/FDA, Medical device product liability
Dr. Sharlin’s experience: My key skill is identifying and developing facts supporting a legal strategy. (1) Drug reviewer at FDA. (2) Expert witness experience: Cases-37, Expert reports-16, Depositions-8, Testimony-1, Successful Daubert challenges-0. (3) Professional experience: Regulatory consultant (25 years), expert witness (10 years). (4) My cases have involved drug and medical device death and injury, patents, mergers, trade secrets, business interruption insurance, product labeling. (5) My skills: biological scientist, statistician, software developer, data integrity specialist, technical writer, educator, and FDA regulatory expert. (6) Talented technical writer, my writing experience includes:  Expert reports, scientific publications, audit reports for FDA compliance, standard operating procedures, FDA submissions, responses to questions from FDA. (7) I write custom software for data mining of safety information from FDA’s adverse event databases:  I extract f...

Paul A. Arpino, PharmD

Newton, Massachusetts
Pharmacist, Pharmaceutical Regulation - Hospital and Ambulatory Pharmacy Practice, Standards of Pharmacy Practice, Medication Errors, Medication Safety, Adverse Drug Reactions, Drug Interactions, Standard of Care, Anticoagulation, Pharmacy Standards, Therapeutic Drug Monitoring, Pharmacy regulations
Extensive knowledge in pharmacy practice, regulatory compliance, medication management and standards of pharmacy practice across a variety of patient care settings. Board Certification in Pharmacotherapy (BCPS). Available as a consultant for both plaintiff and defense cases.

Kathleen F Jackson, R.Ph., Ph.D. (H.C.), FIACP Jackson Audit and Compliance

Alvin, Texas
Pharmacist, Pharmaceutical Regulation - USP <797> <795> <800>, Sterile and non-sterile compounding, FDA 503(a) and (b), State Inspections, Accreditation, Compliance, Critical Point Training, NABP, PCAB, Inspections, FDA Drug Compliance Expert
Kathleen Jackson is a licensed and experienced 36+ year pharmacist with specialized training and experience in compounding and compliance with regulations. She owned and operated a community pharmacy with an emphasis on compounding for 22 years. She has most recently received an NABP Inspector Certification (CISCI) in November 2018. Kathleen was also previously accepted by FDA to monitor a pharmacy as a Drug Compliance Expert. She has presented at several PCCA International Seminars as well as local community clubs and organizations. Kathleen was awarded "Pharmacist of the Month" in March 2002 by PCCA (Professional Compounding Centers of America). She has performed inspections and prepared reports to Boards of Pharmacy related to license suspensions/probation orders. Kathleen has co-authored two articles on Root Cause Analysis in the IJPC (International Journal of Pharmaceutical Compounding). She has also authored several articles in the Texas Pharmacy magazine and the US Pharm...
You can also find Pharmaceutical Regulation Expert Witnesses in:
Massachusetts, Texas, Arizona, and Maryland