QbD Austria provides pharmaceutical organizations with a qualified Information Officer to coordinate and monitor the corporate’s information management and marketing activities.
Managing your information
How far are pharmaceutical companies allowed to go when advertising their products? Which information must be communicated in a summary of product characteristics?
To be fully compliant with legal requirements, a qualified expert has to take responsibility over how information on pharmaceuticals is communicated and marketed.
Responsibilities of an Information Officer:
- They must have a solid understanding of the medical and scientific field to apply all relevant guidelines appropriately.
- They are responsible for ensuring that labeling, package inserts, product information, and advertising for a product align with its approval or registration.
- They need to create product information, instructions for use and mandatory text.
- They bear the responsibility for maintaining up-to-date instructions for use, product information, and mandatory text.
- They must stay informed about relevant changes in regulations, laws, and deadlines and implement them accordingly.
- They coordinate with the relevant authorities as needed.
- They conduct training sessions to raise awareness among sales and marketing personnel about applicable legal regulations.
How we support you
- Patient Information Leaflets (PIL)
- Summary of Product Characteristics (SmPC)
- Advertising materials (adverts, brochures, displays, etc.)
Why opt for the QbD Group?
EXCEPTIONAL RA SERVICES THAT MEET YOUR NEEDS
Contact us for more information or to request a free, no-obligation proposal.