CRED Practical Document Writing and Management

Role of Regulatory Affairs (1)

Corporate/Central

Local/Regional

• Central involvement in development process • Core dossier • Global regulatory strategy • Core labelling profile • IND, CTA, NDA, MAA • Scientific advice • Due-diligence/Reg Intel. • Global SOPs • Pharmacovigilance • Medical • ePublishing • Global business development

• Country/Region specific data • Product information • Local developments and specific variations • Local/regional RA strategy • Technical support, CTAs • Pharmacovigilance • Due-diligence/ Local Reg. Intel. • Local SOPs • Medico-Marketing • ePublishing • Local business development

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