Regulatory Operations could be described as the ‘quiet but rather important engine behind the scenes, keeping operations running smoothly to meet the many diverse needs of the industry’ – therefore Regulatory Operations Optimization and Transformation is at the forefront of change and taking advantage of enhanced and exciting digital possibilities (within Europe and globally). Therefore, key topics of emerging and ongoing interest include: personalized healthcare and how the patient being at the center of their healthcare journey is key, digital transformation, including cloud submissions and automation like RPA and web-scraping, as well as how the future of regulatory operations landscape will evolve and change the skillsets of this organization.
Who is This Track Designed For?
This track is ideal for professionals leading and working in regulatory operations and for those on the agency side assessing and approving dossiers. It may be also of interest to patients and patient advocacy organisations. Professionals involved in regulatory operations, regulatory submissions, eCTD, document management and regulatory solution providers.
The online program is now available. Explore the rich content we offer across 10 thought leadership tracks.
Ronnie Harprit Mundair
Regional Labelling Head - AfME, Canada and LATAM - Senior Director
Pfizer, United Kingdom
Rodrigo Palacios, MBA
Regulatory Policy Lead
F. Hoffmann-La Roche, Switzerland
DIA Europe 2022 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.