QP Current Practices Challenges and Mysteries_Almac_March2012
QP Current Practices Challenges and Mysteries_Almac_March2012
QP Current Practices Challenges and Mysteries_Almac_March2012
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Continued…• Study Specific Documentation– Clinical Trial Application Form (Annex 1)– Protocol– IMPD / sIMPD / SmPC / CommercialSpecifications– IMPD Summary of Changes Document (ifapplicable)– Master English Label Text <strong>and</strong> CountrySpecific Text (as submitted)– <strong>Almac</strong> CTA Questionnaire