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Berghem, the Netherlands
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Berghem, the Netherlands
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Lund, Sweden
9
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Espoo, Finland
16
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Lund, Sweden
23
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Lund, Sweden
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Stockholm, Sweden
24
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Espoo, Finland
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Stockholm, Sweden
25
Audits and Inspections
Stockholm, Sweden
30
Effective Site Management - A two-day course
Berghem, the Netherlands

Clinical Study Protocol Writing

March, 25, 2010, Lund, Sweden

Description
• Clinical plan, product development
• Study design
• Laws, rules and guidelines
• Content according to ICH guidelines
• Objectives, patient population
• Investigational medicinal product
• Registration of efficacy/safety
• Cooperation with data management/biostatistics
• Quality control and quality assurance

Target group
The course is designed for anybody who is planning to or already has started to write clinical study protocols. The course will also benefit anybody involved in the review of clinical study protocols e.g. project managers, clinical research managers, monitors, investigators and other site personnel.



The number of participants for this course is limited to 12.
Download fact sheet for this course
Cost
The cost for the course is EURO 375 + VAT when applying one month prior to the date of the course. An application after that date costs EURO 400 + VAT. The price includes morning and afternoon coffee as well as lunch.