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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What advice do you need?

• Regulatory advice – guidelines, policies, procedures • Development advice – Quality, Non-clinical, Clinical • RMPs/REMS, PIP/PSPs etc. • Issue Management

• Safety/labelling • Product quality • Etc. • Local/regional/international • Formal, Informal

The Organisation for Professionals in Regulatory Affairs

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