Programme

Setting the scene with the new Regulations: CT Regulation


About the speaker
Dr Solange Corriol-Rohou

Solange Corriol-Rohou joined AZ R&D in 2004 and is currently Sr. Director of Regulatory Affairs & Policy for Europe. She is a pulmonologist and an immuno-allergist by training. Over the past 18 years, moving from the French Medicines Agency (formerly known as AFSSAPS) and a specialist physician position at the Hospital of Versailles (France), she has gained strategic experience in drug development for different therapy areas, such as respiratory and inflammation. Solange, in her role as the chair of the Clinical Development Expert Group at the European Federation of Pharmaceutical Industries and Associations (EFPIA), has organized jointly with the European Medicines Agency (EMA) several workshops (e.g. on Modelling & Simulation in 2011, Dose Finding/Dose Response in 2014, Paediatric Extrapolation in 2016). Within ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use), as the EFPIA topic leader, she has participated in the revision of the ICHE11 paediatric guideline and is currently keeping the momentum with the ICHE11A Paediatric Extrapolation Guideline which should be released in 2020. She has also experience working in Innovative Medicines Initiative (IMI) projects. With the PROactive consortium she developed and qualified PROs for COPD patients. As the deputy project leader of the IMI ADAPT SMART project, with all stakeholders (regulators, HTA/payers, patients’ organisations) involved in the consortium, she contributed to align understanding of the impact of MAPPs (Medicine Adaptive Pathways to Patients), to share learnings between all stakeholders, and to allow the field to actively work towards MAPPs implementation.

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