Module 1 2021

28/06/2021

Choosing an Agency for Advice

• Commercial relevance of the market • Location of intended clinical trials • Agency/assessor experience of the therapeutic area • Previous experience with drug class • Company relationship with Agency/assessors

• Exploration for Rapporteur/RMS role • Speed and convenience of access • Previous experiences …….

The Organisation for Professionals in Regulatory Affairs

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In this presentation we will cover

• What advice do you need?

• Why seek advice?

• Advice in the regulatory strategy of SMEs

• When should you seek advice?

• Where should you seek advice?

• How seek advice?

• What to do with the advice?

The Organisation for Professionals in Regulatory Affairs

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