What’s in, what’s out, what’s relevant? – Towards a sensible label

20 June 2018
Utrecht, The Netherlands
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At the June 20th workshop of the Regulatory Science Netwerk Nederland (RSNN), we will share experiences and explore regulatory improvement opportunities for the label. 

The Summary of Product Characteristics (SmPC, or the ‘label’) is a key document in the regulatory process and reflects the outcomes of the discussions between regulatory authorities and the (bio)pharmaceutical industry (the applicant). The label serves as a basis of information for many other documents, such as patient leaflets and physician handbooks. A wide range of indirect ‘users’ are thus exposed to the information in the label, but are excluded from the discussions that shape its content. 

Evolving scientific insight into a medicinal product’s benefit/risk profile does not always find its way into the label. No formal regulatory pathway exists, for example, for including clinically meaningful research results in the label that are generated by independent academic groups or clinicians. On the other hand, some information currently included in the label may not be considered relevant for the intended patient population by some stakeholders.
What’s in the label, what’s out, what’s relevant? During the RSNN workshop on June 20th, we will discuss the information that would ideally be included in the label to match patients’ and prescribers’ needs. Additionally, we will consider the current challenges with amending an existing label.

Speakers include Saco de Visser (ZonMw), Filip Mussen (Janssen), Joris Langedijk (Brabers), Annemiek van Rensen (PGOsupport) and Frans Opdam (NKI). Each of them will reflect on the current SmPC/label information from a different perspective. The afternoon session will continue with discussions in break-out sessions where we want to exchange ideas and views on the future of the SmPC/label. The day will end with a dinner including dinner speeches by Hans Büller (Fair Medicine) and Marie Elske Gispen (RUG) on patient involvement in medicine development and decision-making.

We hope to see you on June 20th!