European Medicine Agency presentation

‘Significant Benefit’ in the European Regulatory Framework for Orphan Medicinal Products

In Clinical Development, Orphan Drug Congress, Orphan Drugs Live by Karina KusovaLeave a Comment

Orphan Drug regulation has changed over the past 30 years. New legislation like Prescription Drug User Fee Act (PDUFA VI) and 21ST Century Cures are changing the shape of the US regulatory landscape.

Last year at the World Orphan Drug Congress USA, we heard from Bruno Sepodes from the European Medicine Agency on the evolution of the ‘Significant Benefit’ in the European Regulatory Framework for Orphan Medicinal Products.

Download his presentation here >>

Join us in 2017 for a look at how legislation will change the shape of the Orphan Drug industry in years to come.

Here is an example session on offer:

Keynote panel: Prescription Drug User Fee Act (PDUFA VI) and 21ST Century Cures – recent and pending legislative efforts to make drugs better for patients

  • Making the drug development process better and more efficient for patients through biomarker development, precision medicine, patient reported outcomes and RWE for regulatory uses
  • Engagement of patients in regulatory decision-making, streamlined drug development and faster applications review – what this means for drug manufacturers
  • How can legislative pieces be improved to continue getting support from Congress?

Jim Greenwood, President and Chief Executive Officer, BIO
Sascha Haverfield, Senior Vice President, Science and Regulatory Advocacy, PhRMA
Max Bronstein, Senior Director of Advocacy & Science Policy, EveryLife Foundation for Rare Diseases
Eric Gascho, Vice President, Government Affairs, National Health Council
Peter Saltonstall, President and Chief Executive Officer, NORD

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