This module explains the need for, and definition of, labeling for prescription drugs and biologic products. It discusses how labeling is developed and maintained throughout the product’s marketed life, the components and structure of prescription drug and biological product labeling, and pertinent regulatory and legal requirements with which they must comply.
The module takes an average of 3 hours to complete.
- 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
Who should attend?
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
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