• Global labeling: the Company Core Data Sheet
• Labeling in the US: Prescribing Information and the Medication Guide
• Labeling in the European Union: The Summary of Product Characteristics and Package Leaflet
• Labeling in Non-US and Non-EU Countries
• Maintenance of product labeling
• Case studies

This program is designed for professionals involved in:

• Medical affairs
• Medical communications
• Medical information
• Medical writing
• Field-based medical affairs support (i.e., medical science liaison)
• Medical call center environment
• Regulatory affairs
• Clinical research
• Professional education, training, and development
• Document management/eSubmissions
• Clinical safety and pharmacovigilance
• Labeling
• Marketing/Advertising
• Ad/Promo

• Upon completion of this module, learners should be able to:

  • Evaluate the purpose of prescription drug and biologic product labeling
  • Compare labeling requirements at the global and local levels
  • Identify the components of the Company Core Data Sheet (CCDS)
  • Recognize the components, structure, and use of the Prescribing Information and the Medication Guide in the US
  • Outline the components, structure, and use of the Prescribing Information (Summary of Product Characteristics) and Patient Labeling (Package Leaflet) in the European Union
  • Identify the regulatory agencies and requirements that govern product labeling for non-US and EU European countries
  • List the departments involved in labeling development and maintenance