DRUG SAFETY INSTITUTE, INC.
MIAMI, FLORIDA

DSI is a subsidiary of Brand Institute and was created in 2004. We are dedicated to furthering the cause of drug safety and risk management issues that will improve safety. DSI will address risk assessment and management issues associated with nomenclature, labeling, and packaging of pharmaceutical and biological products. At DSI our plan is to make the Brand Institute methodology for brand name safety testing even more reflective of the FDA's review process. In addition, DSI offers a medication error prevention analysis for new product labels and packaging and offers its expertise in various risk management strategies. Mr. Phillips retired from the U.S. Public Health Service at the Food and Drug Administration (FDA) in 2004, after 16 years with the Agency. Joining the Agency in 1988, he became the Director of the Division of Labeling and Program Support in the Office of Generic Drugs, where he shared responsibility for the approval of all generic drugs in the U.S. In particular, he developed his expertise in the labeling and safe use of pharmaceutical products. In December of 1998, he became the Associate Director for Medication Error Prevention in the newly created Office of Post-Marketing Drug Risk Assessment (OPDRA), which is now known as the Office of Surveillance and Epidemiology (OSE). Mr. Phillips earned his B.S. in Pharmacy from the University of Houston and completed an ASHP hospital pharmacy residency at the U.S. Public Health Service hospital in Staten Island, N.Y. Mr. Phillips oversees all proprietary & nonproprietary strategy, naming, safety research, labeling, risk management, name submissions, rebuttals, and special consults for DSI. Ms. Fuerst joined Drug Safety Institute's Nonproprietary (USAN/INN) Names Division as Managing Director in 2005, and was promoted to President in 2007. Ms. Fuerst was formerly Director of the USAN Program at the American Medical Association (AMA) and served in various positions during her 18-year tenure with the Program. She was involved in negotiations between the USAN Council, pharmaceutical manufacturers and foreign nomenclature agencies. From 1986 to 2005, Ms. Fuerst was responsible for reviewing submissions, classifying compounds, creating new stems when appropriate and approving and adopting new USAN names. About Us | Nora Roselle Dr. Roselle joined DSI as Managing Director of U.S. Regulatory Affairs in 2007. Prior to DSI, she served as an officer (LCDR) in the U.S. Public Health Service. She joined the Food and Drug Administration (FDA) in 2001 as a Safety Evaluator in the Division of Medication Errors and Technical Support (DMETS), in the Office of Drug Safety (ODS), recently renamed the Office of Surveillance and Epidemiology (OSE). In that role, she evaluated a multitude and diverse array of applications for brand names, line extensions and combination product names utilizing DMETS’ proprietary name evaluation methodology. In July of 2006, she was promoted to a more senior management position as a Team Leader in DMETS. As Team Leader, Dr. Roselle managed DMETS safety evaluators, and oversaw proprietary (brand, line extension, and combination product) name reviews and labeling, risk management consults. Dr. Roselle has published several articles on medication errors. Two of her most widely known name safety articles include, “Metadate ER or Metadate CD?; Drug Topics 2004, Oct 11:62,64” and “Confusion between Methylphenidate and Methadone, Patient Care 2003, Jan 15:76.” Dr. Roselle earned a Doctor of Pharmacy from the University of Maryland (with Honors) and a B.S. in Biology with a Chemistry Minor from the University of Akron (Cum Laude). Nora’s responsibilities at DSI include assisting clients with their U.S. proprietary brand and line extension strategy, naming, safety research, labeling, risk management, name submissions, rebuttals and special consults. Dr. Balamotis reported directly to the EMA’s NRG Secretariat during his tenure with agency. He participated in all name review meetings and communicated meeting outcomes with NRG affiliates. And, while working on the 2014 guidance document, he liaised with Member States and representatives of the Pharmaceutical Industry, coordinating information and input from all relevant parties. He assisted the EMA in conducting technical review of the Product Information (Summary of Product Characteristics, Labeling and Package Leaflets) according to QRD (Quality Review of Documents standards and in evaluating mock-ups and specimens (packaging artwork). He was also involved in the implementation of the new Pharmacovigilance Legislation, which involved the electronic submission of substance data according to ISO IDMP standards in the first EMA’s electronic medicinal dictionary (XEVMPD). Dr. Balamotis is a current member of the BHBIA (British Healthcare Business Intelligence Association) Ethics Committee. founded in 2004, provides the global pharmaceutical and biotech communities with regulatory expertise, strategy, and best practices in brand name and nonproprietary (USAN/INN) name development, name safety research, and comprehensive regulatory solutions.