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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)
EMA’s Experience with Electronic Submissions
Kristiina Puusaari, MBA, PMP
European Medicines Agency, Netherlands
eSubmission Programme Management, Human Medicines Evaluation
EFPIA Position Paper on the implementation of eCTD
Tim Powell
Biogen, United Kingdom
Director, Submission Sciences, Global Safety and Regulatory Sciences
Bosnia & Herzegovina’s Experience with electronic submissions with the Nees format
Jelena Anicic
Agency for Medicinal Products and Medical Devices (ALMBiH), Bosnia and Herzegovina
Quality Assurance Advisor
Improving Patient Safety and Health Systems Resilience Through the Use of Electronic Labeling
Nevena Miletic
Roche, Switzerland
Regulatory Policy Lead
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