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Digital Transformation Showcase
Session Chair(s)
Rodrigo Palacios, MBA
Regulatory Policy Lead
F. Hoffmann-La Roche, Switzerland
Ronnie Harprit Mundair
Regional Labelling Head - AfME, Canada and LATAM - Senior Director
Pfizer, United Kingdom
Do you hear the words ‘digital transformation’ or ‘digital future’ in our sector and think, well what does it apply to and what is the vision? When is it coming and what has been accomplished so far? And who will it impact and benefit? In the 1st of its kind Showcase at DIA – we want you to hear about some key area’s of progress and ‘touch and feel’ some of the future ‘to be’ digital tools and approaches that are being actively worked on; some of which will be at your ‘fingers tips’ soon. In this Digital Transformation session, you will hear a ‘pitch’ from each of our showcase speakers, whereafter you will be able to choose which station you would like to “touch and feel” more from and be able to move around each of the stations in short 10 min slots, so you can learn more about and ‘see’ what is being ‘digitally enabled’. Our overall objective for this type of unique session is that you will leave much more informed, excited and confident about digital advances for both the pharmaceutical sector and patients alike. Learning Objectives: Participants will have the opportunity to view enhanced use of information resources through featured real world demonstrations. Participants will learn how real-life use cases have leveraged structured, coded and connected content, to bring Labeling onto a new paradigm. Participants will have the opportunity to witness first hand, real time collaboration in support of reliance and regulatory convergence See how the unique global IDMP identifiers come to life in real time and leverage use cases such as pharmacovigilance and drug shortages worldwide. Participants will have the possibility to see demonstrations of added value in use of ePI as an active knowledge resource for citizens; patients and their support network.
Learning Objective : Discuss a Labeling process that is based on fully structured, coded product information and designed for quality, efficiency & interoperability. Illustrate FHIR ePI as key standard to exchange Labeling structured content amongst stakeholders. Outline advanced structured content-based health authority assessment. Evaluate potential for enhanced ePI usability with fully structured Labeling content.
Speaker(s)
Labelling Unleashed – The Power of Structured, Coded, and Connected Content
Niklas Jaenich, PhD, RPh
Boehringer Ingelheim, Germany
Head of Global Labeling Operations and Digitization
Transformation of Regulatory Compliance Through Generative AI
Michel De Ridder, MS
Deloitte, Belgium
Partner
Gravitate-Health: Demonstrating Value of Electronic Product Information (ePI) to Engage and Empower Patients
Anne Moen, PhD, MSc, RN
University of Oslo, Norway
Professor, Faculty of Medicine, Coordinator, Gravitate-Health
Dominique Lagrave, PharmD
Accumulus Synergy, United States
Senior Vice President of Regulatory Innovation
Unlocking the Potential of IDMP for Global Exchange of Medicinal Products Data
Malin Kristina Fladvad, PhD, MSc
Uppsala Monitoring Centre, Sweden
Portfolio Officer
Practical Showcase: A Closer Learning Opportunity
Rodrigo Palacios, MBA
F. Hoffmann-La Roche, Switzerland
Regulatory Policy Lead
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