MARKET RESEARCH

Market Research covers a wide range of investigations aimed at studying and understanding the motivations, the desires, the expectations of patients and doctors in the management of the disease and related therapies.

The MRs include focus groups with doctors or patients, investigations on the perception of the pathology, on the motivations that could lead to choose a therapeutic path rather than another.

Good Vigilance Practices (GVP)-Module VI addresses legal requirements applicable to stakeholders regarding the collection, data management and reporting of suspected adverse reactions associated with medicinal products for human use authorised in the European Union (EU).

This module also contains requirements applicable to Marketing Authorisation Holders (MAHs) for the management and reporting of safety data arising in MRPs.

Serious, non-serious cases of suspected adverse reactions originating in those programmes should be reported by MAHs as solicited reports