Global Labeling Conference

The success and safety of drug products heavily depend on an efficient labeling team, particularly during a legal entity change such as a merger, acquisition, or marketing authorization transfer. Such changes can pose compliance risks, leading to potential safety risks, product recalls, and brand damage. However, the development of new labels can be smooth with a well-planned strategy, timeline, and data transfers that follow both companies’ regulations.

Successful labeling harmonization relies on a gap analysis that examines the labeling practices of both companies and identifies any discrepancies. This allows for the creation of a strategy that addresses these deviations and mitigates any compliance risk. If the labeling team lacks the ability to manage this additional workload, partnering with a vendor experienced in legal entity change procedures could be beneficial. The process begins with reviewing the steps to develop new, compliant labels, followed by identifying a strategy that aligns with the company’s goal with a patient-centric approach.

Featured Topics:

• Impact Assessment and Gap Analysis
• Designin a Labeling Strategy
• Data Transfer
• Submission to Health Authorities
• New Label Implementation
• Using LLM, NLP, and Automated Label Text Comparison Technology