Module 19 2021

01/06/2021

Sources of Information

Regulator websites ● FDA, HC, TGA Consultants ● Emergo ● Arazy ● Pacific Bridge Medical

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Conclusions

Join regulatory working groups ● Good regulation needs to be pragmatic ● Don’t be shy showing your knowledge, but remember, patient first! Use the RCP as the basis for work especially in regulated countries Set files/processes up to cover top 5 country requirements (including Japan) and build others from there (use IMDRF TOC) Other countries with no regulations may still have requirements

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