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PAN AMERICAN NETWORK FOR DRUG REGULATORY HARMONIZATION. Mexico May, 2003 Steering Committee WG/GMP WG/D Classification. Rosario D’Alessio PAHO/WHO. DRUG REGULATORY HARMONIZATION FORUMS. International Conference on Drug Harmonization (ICH) European Agency on Drug Evaluation (EMEA)
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Mexico May, 2003
CARICOMGroups of Economic Integrationin the Region of the Americas
Search for common ground within the framework of recognized standards, taking into account the different political, health, and legislative realities in the Americas Region
1. To identify global harmonization issues and their relevance to the region;
2. To identify the stage of development in the current sub-regional group;
3. To identify common obstacles and/or problems;
4. To recommend subjects, strategies and actions to facilitate hemispheric DRH.
The Conference should promote drug regulatory harmonization for all aspects of quality, safety and efficacy of pharmaceutical products as a contribution to the quality of life and health care of the citizens of the Member Countries of the Americas.
The Steering Committee should enable progress between Conferences by coordinating, promoting, facilitating and monitoring harmonization processes in the Americas.
1. To organize meetings, workshops, to carry out recommendations of the Conference.
2.To establish study groups on regulatory topics identified by the Conference as more relevant.
3. To determine preparatory activities necessary for subsequent Conferences.
4.To determine the best methods to resolve issues and reach consensus.
5. To convene meetings at which a quorum of two thirds of the membership are present.
1.To promote participation by all interested parties in the Americas and those invited by the S C.
2.To be held every two years at a date and place determined by the Steering Committee.
3.To adopt all Conference recommendations and conclusions by consensus in plenary sessions. If consensus can not be reached, the different points of view will be recorded.
1. Good Manufacturing Practices
2. Bioequivalence and Bioavailability
3. Good Clinical Practices
4. Classification of Products
5. Counterfeit Drugs
7. Medicinal Plants
9. Drug Registration