Spring Intro 2023

16/02/2023

Where to the CTA docs come from?

Global Regulatory

Regulatory Chemistry Manufacturing and Controls

Legal

Country / Affiliate Regulatory

Pharmacovigilance

• • •

Cover Letter

Application Form (Annex 1)

Finance

Proof of Payment

Manufacturing

• Investigational Medicinal Product Dossier • Investigator Brochure • Protocol • Labels? • Informed Consent Form? • Other National Documents? Medical Safety

Project Management

Clinical Study Manager

Labelling

Publishing

Clinical Supply Chain

Country Clinical Operations / Site monitors / CRO

*The functions involved will depend on your organisation, not all interactions & functions represented

5

Where to the CTA docs come from?

Global Regulatory

Regulatory Chemistry Manufacturing and Controls

Legal

Country / Affiliate Regulatory

Pharmacovigilance

• • •

Cover Letter

Application Form (Annex 1)

Finance

Proof of Payment

Manufacturing

• Investigational Medicinal Product Dossier • Investigator Brochure • Protocol • Labels? • Informed Consent Form? • Other National Documents? Medical Safety

Project Management

Clinical Study Manager

Labelling

Publishing

Clinical Supply Chain

Country Clinical Operations / Site monitors / CRO

*The functions involved will depend on your organisation, not all interactions & functions represented

6