Italian Medicines Agency (AIFA)

This sponsor has funded 7 studies across 1 countries.

PAS funded by this sponsor.
EU PAS ID Status RMP requirement Title Protocol uploaded Results uploaded
5160 Finalised Not included in RMP A regional project to reduce adverse drug reactions due to medication errors in hospital No Yes
5289 Finalised Unspecified Effect of Pharmacist Involvement on Patient Reporting of Adverse Drug Reactions: A Multiregional Italian Study No Yes
5350 Finalised Not included in RMP Surveillance of Adverse Event related to childhood vaccination reported by parents No No
37983 Planned Not included in RMP Comparative Effectiveness and Safety of Drugs used in Rare Neuromuscular and Neurodegenerative Diseases (CAESAR) No No
38308 Ongoing Not included in RMP Comparative Effectiveness and Safety of Immunosuppressive Drugs in Transplant patients (CESIT) No No
43274 Ongoing Not included in RMP Post-marketing evaluation of the benefit-risk profile of originator biological drugs and biosimilars in the dermatological, rheumatological,... No No
105336 Planned Not included in RMP Identifying treatment discontinuation with biological drugs for immune-related inflammatory diseases using administrative healthcare data: a scoping... No No

PAS by Risk Management Plan (RMP) requirement

Italian Medicines Agency (AIFA)

The RMP for a medical product outlines strategies to identify, assess, and mitigate risks, including PAS for further evaluation.

Category 1 studies are imposed as condition of marketing authorisation.
Category 2 studies are imposed as specific obligation of marketing authorisation.
Category 3 studies are required under other circumstances.