Preliminary risk assessement (PRA)
This service completes the data gap analysis by running a low tier risk assessment using the information available at early stage of the project. This allows to identify the areas of the dossiers that will be more difficult to resolve and anticipate the necessary higher tier studies, which would be invisible for a pure data gap analysis. This service also associates a chance of success to the objective pursued.
What is a Preliminary Risk Assessment ?
A Preliminary risk assessment consists of first & second tier risk assessment across all sections of the dossier, with the objective to identify the areas that will require more regulatory effort. Where problems are identified, the preliminary risk assessment will assess if higher tier modelling and/or refinement studies are necessary and evaluate the likelihood of success.
Preliminary risk assessment completes to the data gap analysis and is therefore highly recommended.
Such information is key for strategic decision making regarding the active substance and Product an applicant wants to invest in.
When is a Preliminary Risk Assessment performed ?
A preliminary risk assessment is required at the earliest stage of a registration project. It completes a data gap analysis and comes prior to the launching of a data package generation.
How does ENC perform a Preliminary Risk Assessment ?
The preliminary risk assessment is performed in the same way as for the risk assessment. The difference are that:
- it is generally limited to the first steps (Tier I and sometimes Tier II);
- agreed EU endpoints are not always available or may be re-open during the active substance evaluation. In such case, ENC will estimate the endpoints based on the studies available;
- when data is missing for certain endpoints, ENC will run worst case assumption at Tier I and realistic estimate at Tier II.
What are the services provided by ENC ?
• Rapid evaluation of the acceptability of the risk for all sections of the dossier.
• Identification of the additional data required (higher tier studies).
• Revision of the GAP if some uses are clearly not safe.
• Presentation of the assessment, its results and the related discussions in a clear report.