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Information Outcomes From Regulatory Processes: Regine Lehnert
Information Outcomes From Regulatory Processes: Regine Lehnert
Information Outcomes From Regulatory Processes: Regine Lehnert
regulatory processes
Regine Lehnert
Training workshop: Regulatory requirements for registration of Artemisinin based combined medicines and assessment of data
which are submitted to regulatory authorities, February 2009
Synopsis
Sharing information
Goals
Tools/Ways
- in Europe
among authorities
with the public
- in WHO Prequalification Programme
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Sharing information
Goals
Improving health protection
making regulatory processes more efficacious
avoiding duplication of work
Improving transparency
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http://www.emea.europa.eu
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Atripla
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Assessment
Outcomes
WHO (III)
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Part 1: Abstract
Part 2: All accepted presentations
Part 3: English package leaflet
Part 4: English summary of product characteristics
Part 5: English labelling
Part 6: Scientific discussion
Part 7: Steps taken for prequalification
http://www.who.int/pq
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