Module 1 2021

28/06/2021

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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Why seek advice

• Optimize development strategy • Target Product Profile (TPP) • Target claims/labelling • Market application • Reduce time to market • Lifecycle management • Maximise benefits of international development • Build long term, sustainable relationships • Value proposition for payers & HTAs • Pricing & reimbursement strategy • Commercial strategy • Establish early competitive advantage

The Organisation for Professionals in Regulatory Affairs

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