Module 17 2024

05/12/2024

Does an Agency Influence Regulatory Strategy?

External Influences

Regulatory Strategy

Competitive Products Technology Agencies Patients Patient Advocacy Groups etc.

Regulatory Influences

Regulatory Authorities Guidelines Standards Organizations Etc.

Internal Influences

Regulatory Affairs Product Development Manufacturing Etc.

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Scientific advice meetings important due to changes in technology

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Clarifications

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Timed/milestone meetings

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Establish a relationship early  Don’t wait until you are in trouble  Contact does not always have to be project related. Be a good corporate citizen* As you build your strategy build your relationship Understand the country you are meeting with as they may have specific nuances depending on the type of meeting you are having  Portugal INFARMED

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When/How to approach

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 Pandemic

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