Imputability Clause Samples
Imputability. Imputability is the evaluation of the degree of direct relation between an Adverse Event and the Licensed Product. When a treatment combines several medicinal products, the analysis of imputability first concerns the treatment as a whole and then each of its components separately.
Imputability. Valuation of the relationship between an adverse event (or adverse experience) and a medicinal product. They can be valued using different scales according to the country. ▇▇▇▇▇▇ ▇▇▇▇▇ Médicament uses a 6-degree scale, I4 highly probable, I3 Probable, I2 Possible, I1 Doubtful, I0 not related, I9 Unknown/not available. The adverse reactions concerned by the present procedure are those whose relationship corresponds to one of the 4 degrees above-mentioned I1, I2, I3, I4. Report drafted by a pharmaceutical firm, as the AMM holder and\or the licensee, concerning a marketed medicinal product. This report analyses the information obtained on this product relating to its safety in human in a place and a period of time determined by the regulations. The PSURs are drafted according to a typical plan detailed in the ICH procedures.
Imputability. It is expressly agreed that the sums received by Mr. ▇▇. ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇ CORAL ▇▇▇▇▇▇▇ in this procedure will be charged in any event to any sum that GRAN TIERRA ENERGY COLOMBIA LTD. ends up owing to ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇ CORAL ▇▇▇▇▇▇▇ with respect the working relationship they had.
Imputability. Valuation of the relationship between an adverse event (or adverse experience) and a medicinal product. They can be valued using different scales according to the country. ▇▇▇▇▇▇ ▇▇▇▇▇ MÉDICAMENT uses a 6-degree scale, I4 highly probable, I3 Probable, I2 Possible, I1 Doubtful, I0 not related, I9 Unknown/not available. The adverse reactions concerned by the present procedure are those whose relationship corresponds to one of the 4 degrees above-mentioned I1, I2, I3, I4. • PERIODIC SAFETY UPDATE REPORT (PSUR) Report drafted by a pharmaceutical firm, as the AMM holder and\or the licensee, concerning a marketed medicinal product. This report analyses the information obtained on this product relating to its safety in human in a place and a period of time determined by the regulations. The PSURs are drafted according to a typical plan detailed in the ICH procedures.