20 jun 2018 - RSNN workshop 20 June 2018 - What’s in, what’s out, what’s relevant? – Towards a sensible label

RSNN workshop 20 June 2018
What’s in, what’s out, what’s relevant? – Towards a sensible label

 
Date: Wednesday June 20th 13:30-21:00
Location: Muntgebouw, Leidseweg 90, Utrecht
Registration:  Register here (free of charge)
Target audience: Experts from academia, (bio)pharmaceutical industry, patient communities, regulatory authorities and the medical profession

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 and we will consider the current challenges with amending an existing label. More information on the program can be found here.


We hope to see you on June 20th! 
Register here (free of charge)


For more information or to subscribe to the RSNN mailing list, please contact: anke.kip@lygature.org

About the RSNN
The Regulatory Science Netwerk Nederland (RSNN) is a network of regulatory science experts from industry, academia, governmental bodies and the broader regulatory science field. Our mission is to advance an efficient and effective regulatory system for drug development, marketing authorization and access, and appropriate use of medicines by pooling expertise of all stakeholders, sharing and disseminating knowledge and setting the agenda for further research.