Ensuring Compliance for Pharma Companies Through Local Label Deviations

28 February 2019

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.


Kathleen O’Brien
is Director of Business Development with Amplexor Life Sciences and a 15-year veteran of the translation industry. Kathleen has a background in linguistics and 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.