As well as ensuring compliance with the law, in the pharma/biotech world, there are strict industry codes and regulations in place which organisation must adhere to.
To bring a medicinal product or device to market there is more to be considered than the mammoth task of obtaining sufficient data to ensure it is efficacious, of good quality and safe in order to successfully obtain a marketing authorisation, or CE mark.
In addition to the legal parameters, there are strict Industry Codes of Practice (e.g. ABPI, EfPIA, other local Country Codes) which must be adhered to with regard to the claims which can be made, how scientific information is shared, the promotional materials and activities which can be undertaken, and to whom such data can be shared, to ensure the safety of patients remains paramount and confidence within the Industry is maintained.
So how do you navigate these Industry Codes:
- Exchange of Scientific Information
- Interactions with HCPs
- Fair and Balanced Claims
- Social Media Campaigns
- Joint Working
- Patient Support Programs
- Sponsorships, Grants & Donations
LS Law provides specialist legal and compliance support for the life sciences industries.
Contact us if you need our expert advice and assistance.