Description: Pharmaceutical, Medical Devices, and In-vitro Diagnostic product labeling plays a vital role in obtaining product approvals, maintaining data quality, and ensuring patient safety by providing the required information to safely administer the product. Each region / country has specific regulatory requirements that must be complied with in order to supply products. Such variations in the regulatory requirements, globally, increase the risk of inconsistencies across product labels. Examples of these variations include different indications for use wording implications, device/drug usage, and the need for frequent license number updates. Labeling issues remain one of the top causes of Regulatory violations in recent years, with many organizations taking aggressive action to identify and remediate deficiencies.
In this session, we will review the insights that are preventing high performing organizations from delivering excellence in Global Labeling Management. We will also explore how end-to-end labeling management processes can be fueled by smart automation and analytic solutions supported by robust and efficient global processes. Lastly, we will explore use cases and/or case studies that not only outline the challenges caused by an ever-changing regulatory environment, but also the benefits automation systems can offer to support Global Labeling Management activities.