Pilot Signal Management Expert Group
The Pilot Signal Management Expert Group (P-SMEG) coordinates the signal management process for veterinary medicines authorised in the European Union (EU). This entails activities to determine if there are new risks associated with a medicine, such as side effects.
The main objectives of this expert group include:
- setting up and testing new signal management processes;
- building a sustainable regulatory framework to implement the provisions of the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6) related to signal management.
The P-SMEG is an expert group established with the Heads of Medicines Agencies (HMA) and under the Pharmacovigilance Working Party (PhVWP-V).
The P-SMEG's tasks include:
- identifying, prioritising and assessing safety issues for veterinary medicines by reviewing pharmacovigilance data for safety signals;
- proposing regulatory actions to the PhVWP-V based on detected safety signals;
- preparing and providing training to national competent authorities.
EMA and HMA set up this expert group in January 2022. It is running as a pilot for an initial period of 2 years. EMA will make the results of this pilot public.
The P-SMEG is composed of 12 European experts, including 11 experts nominated by the national competent authorities and 1 expert nominated by the PhVWP-V.
Below (in alphabetical order of the surname) are the current members of the expert group. The members' declarations of interests are available in the European expert list.