CRED Successful and Skilful Communications 2025

Case study – which questions would you ask in this scenario?

You are seeking advice on the registration requirements of a new formulation, which results in a reconstituted solution with a higher pH. The new formulation is more stable in a higher pH solution, thus enabling infusion of the modified formulation at room temperature. This is expected to provide greater convenience to patients while maintaining the considerable clinical benefits of treatment with this medicine. Your position is that similarity between the new and old formulation can be demonstrated with a comparison of the quality parameters and that there is no need for clinical data. Which questions would you include in the request form? Which expertise would you need? Would you ask for a meeting or for written advice?

The Organisation for Professionals in Regulatory Affairs

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Rehearsals for SA meetings

• At least one - with mock-presentations (of all speakers) and a mock-Q&A session (with anticipated questions) • Write out your scripts to make sure messages are crystal clear and simple – and colleagues can take over in case of emergency. Align external experts and tell them the limits of what to discuss • Focus on items of disagreement and prepare counter proposals, if written comments from regulators have been received before meeting • Don’t forget the non-verbal message - your data maybe compelling, but your voice or your body language may tell it differently. Train your presenters to read the body language of your regulators – do they get the message?

The Organisation for Professionals in Regulatory Affairs

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