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Opportunities in Regulatory System Optimisation - How to Maximise the Benefit?
Session Chair(s)
Beata Stepniewska, MPharm
Deputy Director , Head of Regulatory Affairs
Medicines for Europe, Belgium
An efficient, well-functioning EU regulatory system is critical for timely access to medicines. Due to increasing pressure on authorities and industry’s resources, the optimisation of regulatory processes can bring a significant benefit for all stakeholders. The session will focus on possible solutions which can be put in place to improve the efficiency of the regulatory operations.
Learning Objective : You will be able to learn about current inefficiency in the regulatory operations from the perspective of industry & authorities and to discuss some suggestions of measures which can optimize the functioning of the regulatory network and regulatory processes.
Speaker(s)
Working Smarter, Not Harder - Why Do We Need Regulatory Optimisation?
Beata Stepniewska, MPharm
Medicines for Europe, Belgium
Deputy Director , Head of Regulatory Affairs
Regulatory Optimisation as an Important HMA Priority
Hugo Hurts
Medicines Evaluation Board (MEB), Netherlands
Chair HMA Brexit Task Force; Executive Director
Realising the Benefits of Regulatory Optimisation
Sarah Montagne
Bayer plc, United Kingdom
Head UK/IE Regulatory Affairs
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