Presentation (CTI)

OBJECTIVES: A single meeting often stands between a developer and the assessment team before the dossier is built — and it leaves no written trace. This study examined whether the PICO clarification meeting, as conducted, delivers genuine two-way clarification or functions as a procedural formality.
METHODS: A procedural analysis used Regulation (EU) 2021/2282 (Article 8 scoping; Article 5(1) transparency), Commission Implementing Regulation (EU) 2024/1381 (Article 2(3) on requests for further information), developer reports of early operational practice, and the contrasting standard set by Commission Decision (EU) 2024/3082 on minutes of meetings between Commission staff and interest representatives.
RESULTS: The review identified a consistent operational pattern with three features: meetings conducted without audio record or official minutes; limited substantive engagement, with specific scope questions met by generic non-answers; and a unidirectional dynamic positioning the meeting as assessor inquiry rather than mutual clarification. The combined effect is that developers leave without a documented record, without commitments on contested scope elements, and without actionable insight into how the PICO framework will be interpreted at assessment. Dossier development then proceeds under analytical uncertainty, and any later divergence between the assessment team's interpretation and the developer's reasonable expectation cannot be evidenced or readily challenged. A meeting producing no record and no substantive engagement does not function as a procedural safeguard, and sits in tension with the transparency duty the Regulation itself establishes.
CONCLUSIONS: Minutes, recorded answers to submitted questions, and documented scope interpretations would turn the clarification meeting from a formality into a genuine safeguard — improving predictability at no cost to the timeline.