Spring Intro 2023

16/02/2023

Strategic planning: Authoring CTA Components & Considerations

Strategic Planning & Submission Document Development

Compilation, Publishing, Review

Submission to Agencies, Questions & Approval

Are you an author? Core documents i.e. IMPD, IB, Protocol Other Submission docs: Cover letters, Application forms, local templates

Submission plan: Direct to RA? Use of a CRO? Dispatch core packages to affiliates/local teams?

Are you a reviewer? Core document review vs submission package review

Do you develop the submission strategy? Country selection National submission vs EU CTR

Managing the response to questions

Do you compile & publish?

Archiving process

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Strategic planning: Authoring CTA Components & Considerations

Safety / Non-clinical

Protocol

Quality

Clinical

Stability: Is the drug stable at the proposed temperature for the duration of the study?

Engage early!! Advise team during protocol generation

Exposure: Does the dossier support proposed duration of treatment?

Efficacy: What evidence is there that the drug will be efficacious in this setting?

Manufacturing: Has the complexity of the manufacturing process been explained clearly including responsibilities of third party sites?

Suitable end points / clinically relevant – refer to guidance if available

If there are safety signals have they been described / addressed?

Supportive data of any combination of drugs proposed

Does it comply with scientific advice from regulatory agencies (if it was obtained)?

Safety: Have previous submissions demonstrated a side effect profile of concern?

Specifications : Is the specification appropriate for stage of development?

How many patients have already been exposed to the drug globally?

Relevant Authorisations: Are the appropriate manufacturing authorisations / GMP certifications / QP declarations included?

Does it reflect local dosing regimens?

Benefit/Risk: Is B/R profile clearly positive?

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