Training Workshop on Pharmaceutical Development with a Focus on Paediatric Medicines / 15-19 cto!er "##$1 %Regulatory Requirement on Dossier of Medicinal ProductsWHO Workshop, October 2007Sultan Ghani, DirectorBureau of Pharmaceutical SciencesTherapeutic Products Directorate, Health CanadaTraining Workshop on Pharmaceutical Development with a Focus on Paediatric Medicines / 15-19 cto!er "##$" %utlineCommon Technical Document (CTD ICH)ualit! O"erall #ummar! (O#)Training Workshop on Pharmaceutical Development with a Focus on Paediatric Medicines / 15-19 cto!er "##$& %!n "er"ie# of the CTDThe CTD is not a $%lobal Dossier& 'It is an a(ree)*upon common +ormat +or the $mo)ular& presentation o+ summaries, reports an) )ataIncorporates rele"ant ICH (ui)elinesIt is or(ani,e) into +i"e sections-.ll $mo)ules& harmoni,e) e/cept 0o)ule 1 re(ional speci+ic2a3 )ata per re(ional re4uirementsTraining Workshop on Pharmaceutical Development with a Focus on Paediatric Medicines / 15-19 cto!er "##$' %Module $2e(ional .)ministrati"e In+ormation5onclinicalO"er"ie3ualit!O"erall#ummar! Clinical#ummar!Module %ualit!Module &5onclinical#tu)! 2eports Module 'Clinical#tu)! 2eportsClinicalO"er"ie35onclinical#ummaries(ot Part of CTDCTDModule )(DSResult #as the CTD TriangleTraining Workshop on Pharmaceutical Development with a Focus on Paediatric Medicines / 15-19 cto!er "##$5 %CTD Structure6ull )ossier contains 7 $0o)ules& * * - Onl! 0o)ules 2*7 are $CTD&0o)ule 1 re(ion*speci+ic but al3a!s inclu)e) in complete CTD structure0o)ule 2* .ll summaries 8 o"er"ie3s0o)ule 9 C0C ($ualit!&)0o)ule : ;reclinical0o)ule 7 * ClinicalTraining Workshop on Pharmaceutical Development with a Focus on Paediatric Medicines / 15-19 cto!er "##$( %Module ) * CTD Summaries2