In particular, we will deal with and conceptualize the following dimensions: the SUD quality itself, the activities of the harmonization process including the interaction of the parties involved while gathering quality requirements, the knowledge about these parties and the differences in their perception of quality, and the amount of knowledge about quality-related issues.
The International Conference on Harmonization Q8 (R2) includes a requirement that "Critical formulation attributes and process parameters are generally identified through an assessment of the extent to which their variation can impact the quality of the drug product," that is, the need to assess the robustness of a formulation.
Unlike assimilation, where an individual stands to lose his identity by absorption into the mainstream culture, integration involves a mutual recognition and respect of the other -- a harmonization that includes difference rather than denies it.
Suggestions for future harmonization activities included use of a common nomenclature and definitions, mutual recognition and reducing the number of clinical trials.
This harmonization can include the adaptation of program services as well as the implementation of common arrangements for planning, management, financial reporting, and M&E, so as to integrate with the national program or host environment.
Apart from subject-matter specific recommendations, progress can only be achieved with further harmonization of methods, including those for environmental exposure assessment.
EPITARGET is also anticipating the future challenges and requirements in a larger-scale preclinical harmonization of epilepsy studies, including training, data management expertise, cost, location, data safety and continuity of data repositories during and after funding period, and incentives motivating for the use of CDEs.
Groups such as the Global Alliance are exploring how to enable data sharing through various initiatives, including better harmonization, creation of standards and development of incentives [ 2, 3].
Despite the extensive harmonization procedure, some variables, including OA, may continue to be difficult to compare across countries, and interpretation of findings may require particular attention.
