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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Dealing with difficult advice

• Seek understanding of underlying reasons for advice provided • Formally and informally • Seek advice on Agency expectations • Clarify and confirm points of agreement and disagreement • Focus on the science and on the patient • Seek alternative views inside/outside Agencies • Challenge constructively and positively • Work with the Agency to agree a mechanism for challenge • Manage internal company expectations • How to deal with conflicting advice from the EU and US agencies

The Organisation for Professionals in Regulatory Affairs

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