Regulatory Operations
Regulatory Operations continues to be a dynamic, varied, and exciting place to be whether you are an industry colleague, a regulator or a patient. In 2024, we are bringing a different feel to this track with workshops, live fireside chats and some standing up. We want you to engage more directly in hot topics and share your voice as topic thought leaders/SMEs, while also learning about the latest updates in a different but optimal way.
Would you like to be part of a Regulatory Operations “Show and Tell”? Would you like to host a fireside chat? Then we hope you will join us for this special sessions that will enable the audience to experience key digital transformations almost at our fingertips!
Who is This Track Designed For?
This track is ideal for life sciences professionals leading and working in regulatory operations, as well as for those supporting and being supported by this functional group – we would like to invite supply chain colleagues to join our sessions as key collaborators. The track is also intended to be of interest for those on the regulatory authorities’ side, assessing and approving dossiers, and to patient advocacy organizations, supporting initiatives that aim to ensure that the needs of patients are met.
Topic Leaders
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
Key Topics
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Day 1: Tuesday, March 12th, Hall 100
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Day 2: Wednesday, March 13th, Hall 400
Reimagining the Labelling end-to-end process! The case of the EU Centralized Procedure
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Day 3: Thursday, March 14th, Hall 100
Digital Transformation Showcase
Enabling technology for product lifecycle management in Europe
DIA Europe 2023 Highlights
It will provide updates on key developments on the GCP Renovation (ICH E6, ICH E8), Clinical Trial Regulation, the Clinical Trial Information System, data submission, transparency, navigating ethical approval, study design in the digital age, innovative clinical trial designs (umbrella and platform trials, patient centricity), digital tools in development and other hot topics. It should be a must-attend for optimising development programmes and identifying cost savings through efficiency and innovation.