CRED Successful and Skilful Communications 2025

Your interactions with regulators should be …

• Planned early • Part of a global regulatory development plan • BUT don’t forget

• Consultations with regulators are formal occasions and opportunities are limited. Visits must be seen as justified and worthwhile by both company and regulator. It may not be appropriate to solicit advice in all cases • Remember slide in previous webinar on whether you need to meet face-to-face

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If you choose national scientific advice

Questions should be related to ● Future development of product

● Data package and best chance to obtain MA ● Choice of procedure, interest to be RMS Also available for herbal medicinal products and medical device with supporting pharmaceutical product Restrictions • Controversial questions or new topics will be referred to EMA for EU scientific advice • MRP/DCP, only if the NCA is asked to be RMS

The Organisation for Professionals in Regulatory Affairs

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