CRED 8 Presentations

01/07/2024

Think strategically & globally …

Be transparent and build trust ● It is all about the benefits, the risks and the management of risks ● Describe the “knowns”, the “unknowns” and the uncertainties – How well can you describe the benefits and risks so patients and prescribers can make informed decisions and manage treatment – What risk management can you offer to mitigate risks – How much “uncertainty” and how many “unknowns” can you offer to resolve over time

And then, what to do with AI

Focus on the North Star: It is all about the patient …

The Organisation for Professionals in Regulatory Affairs

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Think strategically & globally …

International collaboration is here

Results

2019

2020

2021

2022

Interactions with FDA

454

644 132 224 866

696 117 138 920

692 119 165 950

Interactions with PMDA/MHLW

96

Interactions with Health Canada

125 506

Interactions with any other stakeholders

Project Orbis ● Parallel submission & review with US FDA leading the collaboration ● Reviews, questions and, responses to be shared real time with partners (today TGA, ANVISA, HC, IMoH, HSA, SwissMedic, MHRA; EMA/CHMP not yet(?))

The Organisation for Professionals in Regulatory Affairs

EMA Annual Report 2019-2022 (accessed 28May2023) Not updated in 2024

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