8 Pharmacy Regulation Expert Witnesses Found

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....

Pharmacology- Clinical, Pharmacist - Toxicology, Pharmacist Standard of Care (Critical Care, Emergency Medicine, Geriatrics), Adverse Drug Events, Drug-Drug Interactions, Medication Safety and Errors, Pharmacogenomics, Anticoagulation, Antiarrhythmics, Antibiotic Stewardship, Medication-Related Surgical Complications, Opioid Safety

I currently practice as an Acute Care Clinical Pharmacist Specialist at VA San Diego Health Care System, and I have practiced in clinical pharmacy at 6 different healthcare systems. I obtained a Doctor of Pharmacy degree in 2014 from the University of the Pacific and have been a registered pharmacist in California for 10 years. I completed 2 years of postgraduate pharmacy residency training at VA San Diego Health Care System, with the first year focusing on pharmacy practice in ambulatory care and inpatient hospital settings, including hospice and long-term care, and the second year specializing in critical care pharmacy. I am a Board Certified Critical Care Pharmacist (BCCCP) and have held additional specialty clinical pharmacist positions in emergency medicine and critical care. I have clinical research experience in healthcare institutions and the pharmaceutical industry, having collaborated to conduct phase 2, 3, and 4 clinical trials and retrospective chart review....

Pharmacology- Clinical, Pharmacist - pharmacy regulations, pharmacy standards of care, pharmacist medical malpractice, drug utilization reviews, medication errors, adverse drug reactions, Medicare and Medicaid

...Shaw (Pharm-D) is a Board-Certified Doctor of Pharmacy with a specialization in numerous disease states. He has a specialization certification in Nuclear Medication. Dr. Shaw is also a Reviewing Medical Officer/Independent Practitioner for The Department of Labor/Federal Occupational Health (nationally and state specific). Dr. Shaw has been a Reviewing Adjudication Officer for Healthcare for the State of Georgia for CMS/Medicaid through the Dept of Health and Human Services Dr. Shaw has been in practice as clinical/compound/adjudication pharmacist since 1999 in many diverse settings including hospital, hospital transitional care, community clinic, critical care, compounding, and retail. In addition Dr. Shaw has served in a variety of leadership roles that have contributed to his experience as an expert witness. In particular, Dr....

Pain Management - Medicine, Pharmacist - DEA, DEA Expert, DEA Consultant, DEA Compliance Consultant, DEA Compliance Expert, DEA Red Flags Expert, DEA OTP Expert, DEA Pharmacy, DEA Pharmacy Consultant, DEA Pharmacy Compliance, DEA ASC Compliance Consultant, DEA Researcher Compliance, DEA Ketamine Compliance Consultant, DEA Recordkeeping

Dennis Wichern is a partner in Prescription Drug Consulting LLC, where he focuses his efforts on DEA compliance services, risk mitigation initiatives and the development of corrective action plans to protect healthcare organizations, ASC’s, pharmacies and providers nationwide. His experience includes 30 years of public service as a DEA Special Agent retiring in 2018 as the Special Agent in Charge of the Chicago Field Division where he directed all criminal enforcement and diversion control operations in the states of Illinois, Indiana, Wisconsin, Minnesota and North Dakota with a team of approximately 550 employees. Dennis was the first to develop DEA compliance services and training relating to pain and prescription opioids, SAMHSA MAT and OTP’s regulations, pharmacy and ASC operations, and drug researcher protocols....

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

...He has extensive familiarity with FDA regulations, processes, and procedures, including drug/biologic labeling and compliance requirements. Dr. Ross was the recipient of CDER’s Excellence in Communication and Excellence in Leadership Awards. Dr. Ross has published extensively in book chapters and medical articles. He is a frequently invited presenter at medical conferences, industry meetings, medical societies, and hospital grand rounds. Dr. Ross is an experienced expert witness at the federal and state levels. Dr. Ross has been called upon to express opinions in the areas of medical malpractice, personal injury, negligence, standard of care, and product liability. He has also provided testifying and non-testifying expert witness services in cases involving drug safety, civil securities fraud, patent infringement, pharmacy compounding, and drug adulteration and contamination.

Pharmacist, Pharmaceutical Regulation - Hospital, Outpatient Retail Pharmacy Practice, Standards of Pharmacy Practice, Medication Errors, Medication Safety, Adverse Drug Reactions, Drug Interactions, Standard of Care, Anticoagulation, Controlled Substances, 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.

Pharmacist, Pharmacology- Clinical - Experience in Retail, Community and Hospital Pharmacies for over 35 years, Medication Errors, Wrongful Death, Prescription Drug Abuse, Drug Overdose, Substance Use Disorder, Pharmacy Standards of Care, Pharmacy Law, Pharmaceutical Standard of Care, Drug Interactions.

Extensive knowledge in Board of Pharmacy Regulations, she was a member of the Massachusetts Board of Pharmacy for 15 years, serving as president twice. Additionally, she served as an Executive Committee member of the National Association of Boards of Pharmacy (NABP) for over 10 years, including elected as Treasurer, President and Chairperson of the association. She continues to be involved with NABP on committees and task forces. She served as chairperson for the Stakeholders Coalition on Prescribing and Dispensing Controlled Substances. She has assisted the Board of Pharmacy in writing regulations that govern the practice of pharmacy, she is generally familiar with NABP model regulations and regulations adopted in other states. She has a master's degree in Drug Regulatory Affairs and has over 35 years of experience in community pharmacy and hospital practice. She has been practicing as an expert for 20 years, reviewing over 170 cases for both plaintiff and defendant....

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 40+ 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, expiring June 2023. 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)....