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European Medicines Agency 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 85 75 Fax (44-20) 75 23 70 40 E-mail: mail@emea.eu.int http://www.emea.eu.int

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Guideline for good clinical practice E6(R2)

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Q12 Step 2b Technical and regulatory …

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European Medicines Agency

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