4th Annual Pharma Labeling Compliance Conference

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4th Annual Pharma Labeling Compliance Conference

March 15, 2016 - March 16, 2016

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Pharmaceutical labeling is a constantly evolving and complex discipline for all labeling professionals. Not only are there emerging new regulations that pharmaceutical and generic pharmaceutical companies need to comply with, but when submitting their labels to FDA or EMA there are always different items to document per regulation they are adhering to. Via case study presentations and panel discussions, the conference delegation will coordinate a more robust End-to-End Labeling process while adhering to new guidance’s such as the Pregnancy & Lactation Labeling Rule (PLLR) and new guidance’s with submitting Combination Product labeling.

This conference brings together highly specialized professionals working in labeling from drug companies. Participants will discuss key strategies for attaining efficiency in designing a product label inclusive of core content, confronting stringent timing constraints, translation challenges and adhering to changing FDA guidelines and standards.

Key topics:

  • Develop an End-to-End Labeling model that will improve the entire labeling process
  • Deal with errors that occur when submitting labels in Structure Product Labeling (SPL) Format to achieve compliance with FDA standards
  • Remain vigilant with product safety changes to ensure the label is accurate and depicting all safety information
  • Devise a labeling alignment model that will assist in achieving global labeling harmonization
  • Identify and document branded and generic label updates to ensure compliant product labeling

For more information, visit their website listed below.

 

Venue

Boston
MAUnited States

Organizer

Marcus Evans