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It´s Never Too Soon – Early Access and Early Dialogue in Drug Development
Session Chair(s)
Kate Beaujeux
Senior Regional Regulatory Affairs Director
AstraZeneca, United Kingdom
This session will focus on the key contributions of regulatory science in support of timely access to medicines. This includes strategies for consultations with EMA and/or FDA such EMA/HTA joint advice, national advice, new possibilities based on the EMA “PRIME” scheme and how to prepare for compassionate use programmes.
Speaker(s)
Regulatory Strategies for Early Dialogue: Scientific Advice Including Joint EMA/HTA and National Advice and Pilot Scientific Advice on PASS
Steffen Thirstrup, MD, PhD
European Medicines Agency, Netherlands
Chief Medical Officer
European Early Stage Innovative Medicines Designation (“PRIME” Scheme)
Zaide Frias, PharmD
European Medicines Agency, Netherlands
Head of Digital Business Transformation Task Force
Early Access/Compassionate Use in Europe
Kate Beaujeux
AstraZeneca, United Kingdom
Senior Regional Regulatory Affairs Director
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