Ensuring Compliance for Pharma Companies Through Local Label Deviations
Sponsored by: AMPLEXOR Life Sciences
Date: 28 February
Time: 3PM London/10AM New York
Stay out of hot water with the Health Authorities!
Many global pharmaceutical companies are often faced with a volume of content in the field that has grown to a point where the quality of that labeling is unknown. Assessment of what exists and correcting the process to avoid pitfalls in the future can be a daunting task.
In this session, Kathleen will review a retrospective labeling case study that not only provided data to identify deviations in local labeling, but also shed some light on the path forward. In addition, she will share an overview of options to ensure compliance by leveraging the AMPLEXOR Life Sciences Suite.
Director, Business Development – AMPLEXOR Life Sciences
Kathleen O’Brien is a 15-year veteran of the translation industry with a recognized background in linguistics , She has held various roles in the translation business: vendor, project and account management, as well as new business development, giving her a unique perspective into both translation operations and how translation impacts the globalization needs of her clients in the pharmaceutical and medical device industries. She proactively collaborates with her life sciences client partners on a daily basis to help them set their localization strategies.
Key Learning Objectives
- Step by step considerations for assessing the quality of current state of local labeling
- Short term, mid-term and long-term strategies for achieving global compliance on local labeling and working towards zero percent errors in labeling
- How to maximize technology and AI, including an overview of industry innovations developed exclusively for pharmaceutical companies
- Compliance/Regulation Operations
- Product Management
- Research and Development
- Sales and Marketing
- Senior Management
- Strategy Planning