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MedDRA
- ICH Training
- Training
ASEAN workshop, 17-19 March 2010, Kuala Lumpur, Malaysia
In March 2010, a 3-day ASEAN workshop on MedDRA and its Application in Safety Drug Monitoring was held in Kuala Lumpur, Malaysia. The event was supported by the National Pharmaceutical Control Bureau from the Malaysian Ministry of Health and was attended by ASEAN Regulators from Brunei, Cambodia, Indonesia, Laos, Malaysia, Philippines, Singapore and Vietnam in addition to representatives of local pharmaceutical and multinational companies.
The speakers included experts from the US Food and Drug Administration (FDA), the European Federation of Pharmaceutical Industries and Associations (EFPIA), and from the MedDRA Maintenance and Support Services Organization (MSSO).
Workshop
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Day 1
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MedDRA: an ICH Success Story
Dr. Christina Winter, GSK UK, and ICH MedDRA Management Board member for EFPIA
Coding with MedDRA
Dr. Judy Harrison, MedDRA Maintenance and Support Services Organization (MSSO), USA, with input from Dr. Christina Winter and Dr. Sonja Brajovic
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Day 2
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Safety Data Analysis and SMQs
Dr. Judy Harrison, MedDRA Maintenance and Support Services Organization (MSSO), USA, with input from Dr. Christina Winter and Dr. Sonja Brajovic
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Day 3
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MedDRA Coding and Analysis from an Industry Perspective
Dr. Christina Winter, GSK UK, and ICH MedDRA Management Board member for EFPIA
MedDRA Data Analysis from a Regulatory Perspective
Dr. Sonja Brajovic, Food and Drug Administration (FDA), USA
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