Expert Spotlight

October 2016 - Q&A with Nora Roselle,Vice President, Global Regulatory Affairs, DSI

Dr. Roselle joined DSI - Rockville as Managing Director of Global Regulatory Affairs in 2007 and was promoted in 2012 to Vice President, Global Regulatory Affairs. 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, proprietary (brand, line extension, and combination product) name reviews, labeling and 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).

We sat down with Dr. Roselle to discuss her role at Brand Institute.

BI: Can you tell us a little about your position at brand institute?
NR: I joined Brand Institute/Drug Safety Institute as Managing Director of US Regulatory Affairs in 2007, and was promoted to Vice President, Global Regulatory Affairs in 2012. Some of my responsibilities at DSI include assisting clients with their proprietary brand name and line extension submission strategies, review of name safety data and submission documents, rebuttals, and labeling reviews.

BI: What education and career path did you take to reach your current position?
NR: I have undergraduate degrees in biology and chemistry, and a Doctor of Pharmacy from the University of Maryland. While in pharmacy school, I completed several rotations at FDA, one of which included DMETS, the Division of Medication Errors and Technical Support – this is the group that is now known as DMEPA, the Division of Medication Error Prevention and Analysis, and the rest is history. I joined FDA in 2001 after graduating from pharmacy school and started as a safety evaluator in DMETS.

BI: What was your role at the FDA?
NR: As a safety evaluator, I evaluated proposed brand names for a multitude of applications involving drugs, biologics, line extensions, and combination products. In 2006, I was promoted to Team Leader in DMETS. In that position, I managed and trained DMETS safety evaluators and oversaw proprietary name and labeling reviews.

BI: How do you apply what you’ve learned there to your position here?
NR: My time at FDA really helped shape my knowledge of medication errors and their prevention. Much of what we do at DSI parallels the training, concepts, and thought processes I learned and used while at FDA, and helps shape the name development process our team uses today.

BI: What question do you get asked the most?
NR: Anything and everything that has to do with drug name submission and review, timelines, and requirements for drug names. Things like ‘How long does it take to have a name reviewed?’, ‘What’s required for a name to be reviewed?’, and ‘How many names can be submitted for review at one time?’ The rules and requirements differ and are constantly changing among the regulatory agencies, and I am happy to be able to help guide and provide regulatory recommendations to our clients.

BI: How does name safety play into drug name approval?
NR: A name has to be safe and not promotional to be approved from a name safety standpoint. We want to ensure that a product will be prescribed, prepared, dispensed, and administered to a patient correctly, and without confusion due to its name.

BI: What makes a name “unsafe”?
NR: A proposed name that is too similar in sound and/or appearance to a marketed drug name may have an increased risk of medication errors and even potential harm to a patient, and therefore may be considered ‘unsafe’.

BI: What do you love most about what you do?
NR: I really love the opportunity to work with so many different drug products and client teams all over the world. Name safety evaluation and review is a constantly changing environment, and I enjoy being able to share new learnings and help navigate the ever-changing regulatory waters with our clients.

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