March 15-16, 2016
Optimizing the Labeling Process through Implementing Actionable Strategies that will Achieve Global Compliance and Corporate Goals
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.
Bindu Narang, Director of Scientific Writing and Regulatory Affairs, Sciformix Corporation, will be presenting on “Closing the Gap between Signal Detection and Implementation in the Label”.