Why do I need to know the regulations and laws?
Responsible for a medical information service? You need to know the answers to questions like:
• What medicines information can I legally provide and what is not permissible?
• Which regulations or laws apply in different countries worldwide?
• Are there any relevant global regulations or laws?
• How do they affect the service operations?
• How do I know I have a compliant medical information service?
How this framework will help you
The regulatory framework impacts upon all aspects of the Medical Information Service.
• What information you can provide information to healthcare professionals and how you can provide it
• Providing off-label information in a safe harbour environment
• What you can do to help patients and the general public learn about your medicines…. And what you can’t do
• When a medical information response to a customer could be considered as promotional material, with more stringent rules and restrictions
• The design of your Global Medical Information management system
• Knowing that you are compliant and can pass an audit or regulatory inspection