In this episode, Jacopo Quaranta, Regulatory Affairs Manager, shares his insights with Edoardo Pavan, Commercial Operations Associate, on key regulatory expectations for promotional materials in Italy, and recent procedural updates from the Italian Medicines Agency (AIFA).
Learn what these requirements mean for marketing authorization holders and regulatory teams, including:
- Key requirements for promotional and medical materials under Italian legislation.
- Common pitfalls in the preparation and use of references, and how to avoid misleading or non-compliant claims.
- Recent updates to AIFA procedures for submitting revised product information under the silent approval process.
- Practical considerations for document submission, formatting, and regulatory expectations.
Whether you are managing promotional materials or navigating regulatory updates in Italy, this episode provides experience‑driven guidance to support compliant and effective operations.
