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Marriott Wardman Park Hotel

2020 年 01 月 26 日 1:30 下午 - 2020 年 01 月 26 日 5:00 下午

2660 Woodley Road, NW, , Washington, DC 20008 , USA

Short Course 5: Pharmacovigilance for Medication Errors

Instructors

Ashleigh  Lowery, PharmD, RPh

Ashleigh Lowery, PharmD, RPh

Medication Error Safety Advisor, DMEPA, OMEPRM, OSE, CDER, FDA, United States

Ashleigh is currently an acting team leader in the Division of Medication Error Prevention and Analysis (DMEPA). She has also has worked on postmarket and policy projects on DMEPA's Rapid Response Team. She is a graduate of the University of Maryland School of Pharmacy and completed her PGY-1 Pharmacy Practice and PGY-2 Critical Care residencies at the University of Maryland Medical Center (UMMC) and the R Adams Cowley Shock Trauma Center. Prior to coming to FDA, she worked as a clinical pharmacy specialist and clinical assistant professor in the Cardiac Surgery ICU at UMMC.

Rhiannon  Leutner, PharmD, MBA, MPH

Rhiannon Leutner, PharmD, MBA, MPH

Medication Error Safety Advisor,CDER, OSE, OMEPRM, DMEPA, FDA, United States

Rhiannon Leutner is a Medication Safety Advisor in the Division of Medication Error Prevention and Analysis (DMEPA), Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). She is responsible for the collection, detection, assessment, monitoring, and prevention of medication errors with pediatric drug products. Her duties include analysis of reported medication errors and continuous surveillance of adverse drug events and drug usage in pediatric populations.

Jo  Wyeth, PharmD

Jo Wyeth, PharmD

Associate Director for Postmarket Assessments, OMEPRM, OSE, CDER, FDA, United States

Jo Wyeth is the Associate Director for Postmarket Assessments, serving as a senior-level scientist specializing in the application of risk management principles and leading efforts to implement and oversee medication error pharmacovigilance activities, research and quality assurance activities, and assessment of risk mitigation measures. She also performs complex safety analyses, advises Office and Division management, and provides leadership for planning, program development, policy and program analysis, and the implementation of safety initiatives that support OMEPRM.

Otto  Townsend, PharmD

Otto Townsend, PharmD

Medication Error Safety Reviewer Team Lead, OSE, CDER, FDA, United States

Otto Townsend is a Team Leader in the Division of Medication Error Prevention and Analysis (DMEPA), Office of Surveillance and Epidemiology (OSE), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). Otto oversees the DMEPA team responsible for the pre- and post-market safety review of Anti-infective, Anesthetic, Addiction, Pain, Transplant, and Ophthalmology products. Otto has over 20 years of experience as a clinical pharmacist and pharmacy manager in both ambulatory and inpatient care settings. He received his Doctor of Pharmacy degree from the University of Michigan.

Briana  Rider, PharmD

Briana Rider, PharmD

Medication Error Safety Reviewer Team Lead, DMEPA, OMEPRM, OSE, CDER, FDA, United States

Briana Rider is a pharmacist officer in the U.S. Public Health Service stationed at the FDA where she serves as a Team Leader in the Division of Medication Error Prevention and Analysis (DMEPA). In her role, she is responsible for promoting and protecting the health of the American public by increasing the safe use of drug products through reduction of use errors related to the naming, labeling, product design, and packaging of drug products. Prior to joining DMEPA as a Safety Evaluator in 2016, Briana completed two postdoctoral fellowships. She completed the FDA/ISMP Safe Medication Management Fellowship, where she gained valuable experience focused on medication error prevention and safe medication use.

Celeste  Karpow, PharmD, MPH

Celeste Karpow, PharmD, MPH

Acting Team Leader, DMEPA, OMEPRM, OSE, CDER, FDA, United States

Celeste Karpow is currently an acting team leader in the Division of Medication Error Prevention and Analysis (DMEPA). She also has postmarket experience working on DMEPA's Rapid Response Team which included monitoring medication errors for drug products used under emergency use authorizations during the COVID-19 pandemic. Prior to joining DMEPA, Celeste completed the FDA/ISMP Safe Medication Management Fellowship, where she gained valuable experience focused on medication error prevention and safe medication use. She earned her Doctor of Pharmacy and Master of Public Health degrees from the University of Connecticut and completed her PGY-1 Pharmacy Practice residency at Henry Ford Hospital.

Stephanie  DeGraw, PharmD

Stephanie DeGraw, PharmD

Medication Error Safety Reviewer, DMEPA, OMEPRM, OSE, CDER, FDA, United States

Stephanie DeGraw is a medication safety evaluator in the Division of Medication Error Prevention and Analysis (DMEPA). She is responsible for the evaluation of proprietary names, labels and labeling, medication error reports, and human factors-related submissions for combination products. Prior to joining DMEPA, Stephanie worked as a medication safety analyst for Med-ERRS, a subsidiary of the Institute for Safe Medication Practices (ISMP), and as a community pharmacist. Stephanie received her Doctor of Pharmacy degree with specialized drug safety education and training from Temple University School of Pharmacy.

Millie B. Shah, PharmD

Millie B. Shah, PharmD

Human Factors Team Leader, DMEPA, OSE, CDER , FDA, United States

Millie Shah joined the Division of Medication Error Prevention and Analysis (DMEPA) as a Safety Evaluator in in 2014. In her current role as Human Factors Team Leader, Millie is responsible for evaluation of human factors-related submissions for combination products. Prior to joining DMEPA, Millie completed the FDA/ISMP Safe Medication Management Fellowship, where she gained valuable experience focused on medication error prevention and safe medication use. Millie received her Doctor of Pharmacy degree from Drake University in Des Moines, IA. She completed her PGY-1 Pharmacy Practice Residency at Edward Hines, Jr. VA Hospital.

Sonja  Brajovic, MD

Sonja Brajovic, MD

Medical Officer, OSE, CDER , FDA, United States

Sonja Brajovic is a Medical officer in the Office of Surveillance and Epidemiology (OSE), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). She is responsible for coordination of projects related to the Medical Dictionary for Regulatory Activities (MedDRA), including monitoring MedDRA coding quality of reports in the FDA Adverse Event Reporting System (FAERS). Sonja represents FDA on the International Conference on Harmonisation (ICH) MedDRA Points to Consider workgroup. Sonja obtained her medical degree in the former Yugoslavia.

Melissa  Burns, MS

Melissa Burns, MS

Senior Program Manager, Office of Combination Products, OCPP, OC, FDA, United States

CAPT Melissa Burns is a Senior Program Manager in FDA’s Office of Combination Products (OCP). In this role, she is responsible for coordinating activities related to combination product review and regulation including development and review of guidance documents, regulations, and procedures and policies. Prior to joining OCP, Melissa worked for several years in FDA CDRH. Melissa worked for several years in the private sector including positions with a medical device manufacturer, a hospital, a healthcare architecture firm, and a consulting firm. Melissa received a Bachelor of Science degree in Mechanical Engineering from Virginia Tech and a Master of Science degree in Biomedical Engineering from The University of Connecticut.

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