Pharmaceutical Naming Regulation: Understanding the Latest Developments – Webinar Recording/Transcript
Will your proposed drug name stand up to FDA scrutiny?
The FDA’s recently released naming guidance has several key additions and changes you must understand when developing names. Failure to follow the guidelines could create confusion and lead to medication errors.
No one test or standard is adequate to determine whether a proposed name might contribute to medication errors. The FDA advocates the use of a combination of different, complementary tests to identify and remedy potential sound-alike and look-alike confusion with existing drug names.
Fortunately, Susan M. Proulx, PharmD, Managing Director, Drug Safety at Leaderboard Branding, is an international leader in preventing medication errors due to brand name confusion. She’ll explain the FDA’s current thinking on best practices for developing and selecting proposed proprietary names.
- How the prescreening process relates to attributes that may contribute to medication errors in naming drugs
- Suggested methods of evaluating the risk of medication errors related to naming
- The FDA process for notifying applicants that have similar names in the FDA queue
- The phonetic and orthographic computer analysis (POCA) criteria and its use in evaluating name similarity
- The FDA-suggested process for evaluating promotional aspects of a proprietary name
- The tasks necessary for conducting name simulation studies
Are you confident you can create new drug names that won’t cause confusion? This presentation with a drug-naming expert will get you there.
Meet Your Presenter
Susan M. Proulx, PharmD is Managing Director, Drug Safety at Leaderboard Branding. Prior to this position, she was president of Med-ERRS for nearly 20 years. She was also Vice President of Operations for the Institute for Safe Medication Practices (ISMP US), the parent company of Med-ERRS for five years. Over the course of her 25-year career in medication safety, working specifically with the pharmaceutical and biotech industries, Dr. Proulx is an expert in all aspects of drug product-related safety issues. In addition to being an international leader in the industry in preventing medication errors due to trademark (brand name) confusion, she also oversees numerous projects related to improvement of medication packaging and labels to increase clarity, ease of reading and to meet regulatory approval, and has led company-wide medication safety initiatives for the pharmaceutical industry.
Who Will Benefit
- Pharmaceutical and biotech people involved in the development and submission of proprietary names to the FDA.
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Jan. 11, 2022