Back to Agenda
Reimagining the Labelling End-to-End Process! The Case of the EU Centralized Procedure
Session Chair(s)
Gabriele Breda, PhD
Research & Innovation Director
ProductLife Group, France
Barbara Briggs, PhD
Global Strategic Labelling Lead
UCB Biopharma UK, United Kingdom
Preparing labelling content for submission and authorisation today is still a very convoluted manual process, which involves lots of transcription and adaptation to meet regulatory requirements. Furthermore, downstream processes such as translations, artwork creation and compendium publishing are equally dependent on manual steps, not to mention the upstream core labelling conformance checking. Obviously, basic MS Word (copy/paste) is still the number one tool in a Regulatory Operations professional’s toolkit and productivity has reached its limits. Cost of poor quality is high, and mitigating risks of labelling mistakes becomes increasingly difficult. Meanwhile, digital technologies have advanced, and they are ready to transform this space. In this session, we will reimagine the labelling end-to-end process thanks to digital technologies, with a focus on the EU centralized procedure, where 96% of marketing authorisations are based on languages other than English. We will discuss how modern content and notably translation technologies can support the challenge of managing all EU/EEA languages, with a focus on achieving and maintaining the highest quality and regulatory compliance whilst improving productivity. Industry experience and lessons learnt will be shared. Learning Objectives: Recognize the typical challenges with regard to end-to-end EU centralised procedure for labelling, from authoring to translation and update cycles; Assess the importance of adopting emerging content and language processing innovations, in order to modernize regulatory practice; Gain insight into the experiences, lessons learnt and key success factors for a sustainable digital transformation - meeting both the regulators’ policy standards for patient safety and company’s (global) objectives. For a Global Pharma organisation, EU CP labelling is just one of the many Global Labelling challenges.
Learning Objective : After this session, participants will recognise the typical challenges with regard to End-to-End EU centralised procedure labelling, from a content authoring as well as a translation perspective. They will identify the impact of moving to structured labelling (ePI) as well as the importance of adopting emerging language & content processing innovations, in order to modernise regulatory practice.
Speaker(s)
Digital Transformation in Regulatory Operations in Europe: Key Success Factors
Gabriele Breda, PhD
ProductLife Group, France
Research & Innovation Director
End-to-End Labelling Digitisation Vision: Understanding the Role of Digital Technologies
Patrick Middag, MBA, MSc
Servier, Belgium
Principal Lead Regulatory Affairs
Matthias Heyn, MA
RWS, Belgium
Vice President Language Technologies
Digital Transformation in Labelling – Industry Return on Experience
Laurence Brihaye, MA
Industry, Belgium
Industry representative
Panelist
Jasper-Hugo Brouwers
MEB, Netherlands
Head of corporate affairs, stakeholders engagement and medicines use
Have an account?