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Regulatory Operations

Regulatory Operations optimisation and transformation continues to be at the forefront of change across both the private and public sectors. We are now seeing real progress in the implementation of the EU-wide telematics strategy. There are many ongoing topics linked to digital transformation such as IDMP and ePI, as well as emerging technologies for structured data and cloud to facilitate collaborative reviews between regulators and new thinking around ’Personalised Health Care - Putting the patient first’ that are important for us to discuss and share updates on.

Who is This Track Designed For?

This track is ideal for life sciences professionals leading and working in regulatory operations and regulatory labelling, including those supporting and being supported by these functional groups. It is also intended to be of interest for Health Authority professionals assessing and approving dossiers, and organisations and vendors supporting this effort, including patient advocacy organisations that support initiatives that aim to ensure that the needs of patients are met.

Topic Leader

Kate Porch

Kate Porch

Associate Director, Global Labeling Centre of Excellence

Johnson & Johnson, United Kingdom

Tim Powell

Tim Powell

Director, Submission Sciences, Global Safety and Regulatory Sciences

Biogen, United Kingdom

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