Spring Intro 2023

16/02/2023

Understand Your Role in the organisation

Understand who else is involved and the CTA process……

Sponsor – Legal representative/ Applicant

Country specific or Hubs

Regional experts

Collabo ration

Affiliate

Area Hub

Company HQ

External Expert

CRO

Specific expertise/ Consultant

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Your Role In the CTA Process

Where do you start? ● Understand your role and deliverables in the process

Submission to Agencies, Questions & Approval

Compilation, Publishing, Review

Strategic Planning & Submission Document Development

• Is a CRO involved? • Do you submit directly to Agencies? • Do you dispatch core packages to affiliates/local teams? • Managing the response to questions • Archiving process

• Are you an author?

• Are you a reviewer? Core document review vs submission package review • Do you compile & publish?

• Core documents i.e. IMPD, IB, Protocol • Other submission associated documentation: Cover letters, Application forms, local templates, • Do you develop the submission strategy? • Country selection • National submission vs EU-CTR

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