Now in its 11th year, Pharma Packaging and Labeling is back to deliver key, actionable insights into very latest regulatory requirements, technological innovations, strategic developments, and how to implement them into your packaging and labeling chain with both maximum efficiency and minimal cost.
With evolving regulations and tougher anti-counterfeiting rules, ensuring patient safety and the right systems are in place is more crucial than ever. Meeting the deadlines and adhering to regulations will not only ensure compliance but will also deliver huge benefits to your business and the industry.
We look forward to welcoming you to Philadelphia on the 20st and 21nd of February 2019 for what is sure to be another year of insightful, interactive and informative panels, round tables and presentations on issues in commercial packaging and labelling which matter to you!
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. David will discuss options for managing the path forward by leveraging the AMPLEXOR Life Sciences Suite.
BE SURE TO VISIT US
Did you know that AMPLEXOR Life Sciences is the only partner you need to deliver global market-specific content? From multi-lingual content creation, to content management to publishing, AMPLEXOR Life Sciences provides end-to-end solutions tailored to your needs. Stop by and visit our life sciences experts to learn more!
AMPLEXOR Life Sciences Experts Present “Ensuring Compliance for Pharma Companies Through Local Label Deviations Stay out of hot water with the health authorities!”
ABOUT THE PRESENTERS
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.
Kathleen proactively collaborates with her life sciences client partners on a daily basis to help them set their localization strategies.
David Gwyn has more than 25 years of experience in the Life Sciences industry, and is a seasoned executive with an extensive proficiency in delivering solutions to clients in the areas of content management and collaboration. As a global solution architect for AMPLEXOR Life Sciences, David’s main focus is aligning customer needs with the capabilities of the company’s Life Sciences suite to ensure that the solution meets the needs of the customer. David also leads the DIA EDM Submission Reference Model team, which has developed a document architecture for use when designing and building content management solutions. This architecture has been leveraged by numerous companies and vendors to provide submission management solutions that are compliant with global regulations.