Insights

In the pharmaceutical field, congresses, meetings, and scientific events remain a key tool for education and professional engagement. To be effective and sustainable, event strategies must be clearly aligned with their intended objectives and with the applicable regulatory framework.One of the most frequent sources of regulatory risk is the misclassification between CME and non‑CME events, or an inadequate alignment between the event format and the company’s actual goals.

CME events are accredited educational initiatives managed by authorized providers. In this context, the provider is responsible for the scientific program and educational objectives, while pharmaceutical companies may only participate through compliant sponsorship. Promotional activities must remain clearly separated from the educational content in order to safeguard independence and credibility.

Non‑CME events, although not subject to accreditation requirements, are not exempt from regulation. They must still maintain a clear technical‑scientific purpose and comply with applicable rules on promotion, hospitality, and interactions with healthcare professionals. Companies may have greater flexibility in defining content, but the event format must remain coherent with the declared objectives of the initiative.

Regulatory issues commonly arise when the selected event format does not accurately reflect the nature and objectives of the event.
Typical critical situations include unclear roles and responsibilities between organizers and sponsors, delays in meeting regulatory requirements, or the incorrect application of CME‑style rules to non‑CME events and vice versa.

Such misalignments may expose companies to regulatory findings and generate internal uncertainty between the internal functions involved like Medical, Marketing, and Compliance/Regulatory.

Regulatory scrutiny of scientific and promotional events is now a recurring activity, representing a concrete risk factor for companies, with increasing focus on the coherence between objectives, event format, and execution. As a result, companies are required to adopt a structured and risk‑based approach from the earliest planning stages.

RPN supports pharmaceutical and life science companies in the overall management of scientific and promotional events, including the correct classification of initiatives and the preparation and submission of AIFA sponsorship requests, in line with Italian regulatory requirements.