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Early Access Tools: 10 Years’ Experience and Lessons Learned with Conditional MAs in EU
Session Chair(s)
Zaide Frias, PharmD
Head of Digital Business Transformation Task Force
European Medicines Agency, Netherlands
This session will look at the experience accumulated over 10 years and explore some of the challenges identified by various stakeholders for the early access tool of conditional marketing authorisation (MA). The latter include variable uptake in therapeutic areas, reasons for the apparent reluctance in applying for this regulatory pathway, difficulties with establishing initial positive benefit-risk balance and confirming it through generation of comprehensive data post-approval.
Speaker(s)
Elizabeth Vroom
Duchenne Parent Project, Netherlands
President
Karin Van Baelen, PharmD
Janssen, Belgium
Head, Global Regulatory Affairs
Scientific Assessment and Regulatory Decision Making
Tomas Salmonson, DrMed, PhD
Critical Path Institute, United States
Partner
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