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REGULATORY TRACK - Session 4: Digitalisation
Session Chair(s)
Romanca Pekurari
Country Lead - Serbia and Montenegro, IQVIA, Serbia
Although the global response to COVID-19 pandemic pointed out the importance and potential of digitalization of the submission, review and approval process of regulatory data for medicinal products, the digital revolution in Balkan region is still very slow. Joint strategy of Regulatory Agencies/Regulators, Industry and our Associations must be full enablement of the digital infrastructure as a priority that will move us towards improved data oversight and quality as well as putting us on track of digitalization together with EU countries. In this session we will share the experiences and good practices related to electronic submissions and implementation of eCTD and NeeS.
Speaker(s)
Kristiina Puusaari, MBA, PMP
Digital Business Transformation Programme eSubmission Senior Coordinator, European Medicines Agency, Netherlands
EMA’s Experience with Electronic Submissions
Tim Powell
Director, Submission Sciences, Global Safety and Regulatory Sciences, Biogen, United Kingdom
EFPIA Position Paper on the implementation of eCTD
Jelena Anicic
Quality Assurance Advisor, Agency for Medicinal Products and Medical Devices (ALMBiH), Bosnia and Herzegovina
Bosnia & Herzegovina’s Experience with electronic submissions with the Nees format
Nevena Miletic
IFPMA ARN Chair Advisor and Regulatory Policy & Science Chapter Leader, F. Hoffmann-La Roche Ltd, Switzerland
Improving Patient Safety and Health Systems Resilience Through the Use of Electronic Labeling
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