CRED Successful and Skilful Communications 2025

Where do you go for advice?

Herbal extract

You have questions regarding the viral safety prior to initiating clinical trials

HMPC/CHMP or National?

National, e.g. PEI (Germany) or ANSM (France)

The Organisation for Professionals in Regulatory Affairs

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If national advice – how do you choose the country?

• Expertise in a particular therapeutic area, class of drugs or scientific advances • Recognition of disease or therapeutic area in country • Is the particular country one of the major markets for the product • Accessibility of the regulator - ease and speed to arrange a meeting • Company’s own experience BUT • Risk of receiving differing advice, if it is sought from different countries Don’t expect to be able to circumvent any advice you don’t like

The Organisation for Professionals in Regulatory Affairs

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