E-Book | May 16, 2023

IQVIA Labeling Compliance Solutions

Source: IQVIA Safety & Regulatory Compliance

By Ankit Tyagi, Associate Director, Regulatory Affairs and Drug Development Solutions, IQVIA; Rama Mohan Rao Chikkam, Senior Director, Global Regulatory Operations and APAC RA, Regulatory Affairs and Drug Development Solutions, IQVIA; and Donald Palmer, Senior Regulatory Affairs Director, Regulatory Affairs and Drug Development Solutions, IQVIA

GettyImages-1163506017 labeling

Regulatory labeling compliance is crucial to ensure the safe and effective use of drugs and devices. It involves an error-free verification process that meets health authority regulations and industry standards using data from clinical information and core safety information (Company Core Data Sheet – CCDS) of a drug product.

This core label information is frequently implemented as a regional label, including product information, patient information leaflets, and artworks (primary container labels and cartons). However, because regulatory labeling requirements differ from one country to the next and new rules are frequently put into place to update labeling documents, it makes it very difficult to get things right.

If there is a compliance error during this process, it can lead to the following risks:

  • Patient safety and misuse of the drug;
  • Product recalls;
  • Costs of drug recalls and fines;
  • Damage to the brand image; and
  • Resource and time loss.

Learn how by having a strategy for “core-to-carton” compliance, drug developers can avoid risks for patients and their company.

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