| Dates |
Day 1: 09.10.2018 Full day 8h45 - 12h30 / 13h30 - 17h. (normal class room, 0th floor, room B09.2125A) Day 2 : 11.10.2018 - Half - Day 13h - 17h. - Teach Lab 1716; New DAY 3 : October 12 Full day 9h - 12h - 13h - 16h - Teach Lab 1716; Day 4 : 16.10.2018 - Half - Day 13h - 17h. - Teach Lab 1713; New DAY 5 : October 19 Full day 9h - 12h - 13h - 17h - Teach Lab 1716; Examination : 08.11.2018 - Half - Day 13h - 17h. - Teach Lab1716 |
| Intervenant-e-s |
Serge Rudaz, professeur associé, UNIGE, Dr Julien Boccard, UNIGE, Dr Jean-Marc Roussel, Independant Consultant,Analytical Methods Development and Validation Co-Designer, NeoLiCy software for statistical assessment of analytical method's life cycle
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| Description |
The demonstration of the ability of an analytical method to quantify is of great importance to ensure quality, safety and efficacy of pharmaceuticals. Consequently, before an analytical method can be implemented for routine use, it must first be validated to demonstrate that it is suitable for its intended purpose.
The analyst refers to guidelines and regulatory documents, and therefore the validity of the analytical methods is dependent on the guidance, terminology and methodology, proposed in these documents. It is therefore of prime importance to have clear definitions of the different validation criteria used to assess this validity.
The harmonization of validation of analytical procedures was developed by numerous members of the scientific community to understand the objectives of a procedure and to propose protocols that will include these criteria and these objectives. The need to validate methods is obvious and the procedures for performing a rigorous validation program are now relatively well defined. Guides of validation (e.g. SFSTP) were elaborated to help the pharmaceutical industry as well as the various scientist involved in the domain to validate their analytical procedures (for bulk drug and pharmaceutical specialties) and biopharmaceutical procedures (procedures implied in pharmacokinetics studies and of bioequivalence), respectively. Because statistical evaluation of validation results and validation reporting is a major challenge for every analyst, a new statistical and experimental approach based on the accuracy profile was elaborated and evaluated on different types of applications.
This series of lectures and practices will help you to understand the actual definitions in method validation and to show you the latest statistical tools which can help you producing more reliable results faster and in a consistent manner. A comparative commentary of official documents regulating validation of analytical methods (ICH, FDA, EMEA, ISO, etc.) and the understanding in statistical requirements will help to consider some validations protocols and examples. Finally, insights estimating the measurement uncertainty will be given. Thus, even this aspect is not a direct part of method validation, a judicious use of the validation data may help to estimate the uncertainty that should associated with routine results. The latter is of utmost importance for all laboratories that need to provide quantitative results, in order to guarantee their quality and their compliance with the imposed specifications.
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