Sentence examples for harmonized guidance from inspiring English sources
An AAPS workshop on "Stability Challenges not Addressed by Harmonized Guidance" was held on April 3rd – 4th, 2017 at Hilton Washington, D.C./Rockville Hotel and Executive Meeting Center, Rockville, MD.
As this problem relates to real-world development, manufacturing, distribution, life-cycle management, and use of drug substances and products for which no or limited harmonized guidance exists, SME and attendees raised and discussed the following points: 1.
Current harmonized guidance dictates that the hold times for drug substance intermediates, product intermediates, and bulk product are systematically established, but does not fully address the specific requirements for the bulk hold time stability study.
Harmonized guidance for GLP compliance promotes consistency among EU member states in which data are generated (EU 2004).
It is a challenging task to give harmonized guidance to members who find themselves in different national situations.
The increased interest and application of chemical screening methods based on chromatography and MS has resulted in a need for more detailed and harmonized guidance and criteria for validation of such methods [ 29, 30].
It becomes readily apparent that the risk assessment of nanomaterials to be performed under this regulation may become challenging, and for harmonized evaluation specific guidance has to be developed.
Guidance on harmonizing data appliance deployment with organizational IT policies.
During this expansion, improvements and additional features will be implemented to reflect lessons learned in the pilot, including: Guidance on harmonizing data appliance deployment with organizational IT policies Improved handling of QA/QC.
This interim guideline is intended to provide guidance until the completion of on-going research activities and the development of globally harmonized device performance specifications.
It would work to establish harmonized HCW registration, licensing and migration systems in cooperation with national ministries of health and other regional actors using empirically based guidance to most effectively obtain, analyse, and provide feed back of this information.
