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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Where seek advice?

Europe • EMA

• EU guidelines and procedures • Centralised Scientific Advice • National agencies • Local guidelines and legislation • National scientific advice • Other agencies / stakeholders • Advice from payors and HTAs • National agencies for Environmental Risk Assessment • Combined meetings

• EMA / HTA • EMA / FDA • EMA / Medical device …?

The Organisation for Professionals in Regulatory Affairs

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