Module 12 Presentations

End-to-end regulatory process usually managed in RIMS

End-to-end process

Implement change

Prepare dataset

Track & process of 3 rd acknowledgem ents

Update Registration details

Define submission plan

Submit IDMP & dossier to HA

Review, update and finalize submission plan

HA decision

Submit xEVMPD data

Author content

Publish

Plan content

Change

Stakeholders involved

Pitfalls to avoid

Key Takeaways

• Start from top to bottom: high-level processes with a clear goal and outcome and then drill down to the details • Document the process, dependencies, sources of information, roles and responsibilities

Regulatory Operations

• Focus too early in the process design on the details and roles and responsibilities

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Regulatory CMC

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Overcomplicating the process which results in unnecessary lengthy and inefficient processes

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Labeling

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Regulatory Strategy / Submission Managers

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Neglecting stakeholder involvement

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Quality Affairs

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Agree with all stakeholders involved!

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Ignoring continuous improvement

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• Data Governance Committee / Members

The Organisation for Professionals in Regulatory Affairs