ICH Update: Developments and Future Directions. IV Pan American Conference on Drug Regulatory Harmonization Boca Chica, Dominican Republic 2-4 March, 2005 Mike Ward Health Canada. A Unique Approach. International Conference on Harmonisation (ICH) was created in 1990
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IV Pan American Conference on Drug Regulatory Harmonization
Boca Chica, Dominican Republic
2-4 March, 2005
Endorses topics, guidelines and monitors progress
Following over a decade of significant achievements in the harmonization of quality, safety and efficacy requirements for the registration of new drugs in the three ICH regions, is the work of ICH mostly done? Will ICH become a maintenance-only organization?
Appropriate time to evaluate the future of ICH to ensure:
Dr. Yves Juillet (European Industry)
Mr. Mike Ward (Health Canada)
“To promote a mutual understanding of regional initiatives in order to facilitate harmonisation processes related to ICH guidelines regionally and globally; and to strengthen the capacity of drug regulatory authorities and industry to implement them.”
Interest also expressed in:
- technical assistance expressed
- review process and data assessment
- joint GCP inspections