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Thursday, February 7 • 09:15 - 10:15
#S0105: Opportunities in Regulatory System Optimisation - How to Maximise the Benefit?

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Component Type: Session

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.


Beata Stepniewska, MPharm


Working Smarter, Not Harder - Why Do We Need Regulatory Optimisation?
Beata Stepniewska, MPharm

Regulatory Optimisation as an Important HMA Priority 
Hugo Hurts

Realising the Benefits of Regulatory Optimisation 
Sarah Montagne

avatar for Hugo Hurts

Hugo Hurts

Chair HMA Task Force; Executive Director, Medicines Evaluation Board (MEB)
avatar for Beata Stepniewska

Beata Stepniewska

Deputy Director , Head of Regulatory Affairs, Medicines for Europe, Belgium
B.Stepniewska after an academic career at the Fac. of Pharmacy as Head of the Dep. of Pharm. Law and Pharmacoeconomics, joined the industry as Head of the Regulatory Dep for PLIVA Krakow. She has now been with the European Generic medicines Association (now Medicines for Europe) since... Read More →
avatar for Sarah Montagne

Sarah Montagne

Bayer PLC
Sarah Montagne holds a Bachelor of Science 2(1) Degree in Toxicology and Law. In her current position she is responsible for addressing EU regulatory policy topics impacting on the Company and taking operational responsibility for the UK regulatory team based in Reading, UK. Using... Read More →

Thursday February 7, 2019 09:15 - 10:15 CET
E1 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  01 Stakeholders and Regulatory System Optimisation, Session
  • Featured Topics Regulatory Science
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