The services that Di Renzo Regulatory Affairs can offer in this sector are the following:
- Early stage
- Taking on the role of Scientific Service Responsible Person
- Taking on the task of maintaining technical relationship with AIFA and with the single Italian region
- Registration into the AIFA-IMS and for the notification of promotional materials
- Control of the company’s co-promotion and exclusive sale rights agreements
- Examination, drafting and submission of the documentation
- Assessment of the compliance of the promotional materials intended for the health professionals
- Assessment of the suitability of the websites and social networks intended for health professionals
- Drafting of clinical expertise from literature and texts intends for pharmaceutical sales representatives.
- Other activities
- Refresher company courses on current regulations relating to advertising, scientific information and privacy with release of attendance certificates
- Drafting or revision of standard operational procedures (SOPs)
- Company audits
- Assessment of the suitability of the requirements pharmaceutical sales representatives (ISF)
- Transmission of the sheet with the annual visits of the ISFs to doctors via the IMS-AIFA portal
- Registration of the ISFs for the relevant regional territory
- Creation of the ISF identity cards according to the requirements of the regional resolutions
- Assistance to obtain the certification for Scientific Information according to the guidelines of Farmindustria
- Assessment of advertising for the public regarding medicinal products for human use classified as SOP (no prescription) and OTC, application for the authorisation to the Ministry of Health and authorisation procedure
- Development of artworks, brochures and advertising materials and cooperation in the development and update of websites
- Assistance for promotional materials intended for other European countries.