Solange Corriol-Rohou
Trainer
Solange Corriol-Rohou, a pulmonologist/immuno-allergist by training, joined AstraZeneca R&D in 2004 and is currently Sr. Regulatory Affairs & Global Policy Director. Over the past 20 years, moving from the French Medicines Agency /EMA and academia to the pharmaceutical industry, she has gained strategic experience in respiratory, inflammation and oncology drug development.
She is quite active within EFPIA, ICH and IMI/IHI, and passionate about paediatric drug development and drug development optimisation. She is currently leading the AZ Paediatric Work Group. She has also joined ICH to complete the revision of the E11 Paediatric guideline, and is keeping the momentum with the E11A Paediatric Extrapolation guideline. As a board member of EFGCP, involved in the EFGCP Children Medicines Working Party, she is used to organise the EFGCP Annual Paediatric conference, has been actively involved in the Good Lay Summary Initiative, and is currently involved in the EFGCP-EFPIA cross border initiative aimed at facilitating patients access to clinical trials. Among other initiatives, she is also leading with an academic on behalf of Enpr-EMA the Paediatric Clinical Trial Site Quality Criteria Initiative.
Some years ago, Solange, in her role as the chair of the EFPIA Clinical Development Expert Group organized jointly with the EMA several workshops (e.g. on Modelling & Simulation, Dose Finding/Dose Response, Paediatric Extrapolation). She has recently been involved in critical issues, such as Complex Clinical Trial Designs, the use of Digital tools in drug development or Paediatric Unmet Medical Needs; this is why she organised on behalf of EFPIA a multistakeholder workshop on Digital endpoints which has paved the way to optimise the qualification framework. She has also experience working in public-private partnership projects and quite recently, she proposed a new project to IHI as part of the Rare Disease Moonshot initiative.
She has also published over 50 scientific papers in peer-reviewed journals.
Regulatory Affairs - Training Programme Regulatory Affairs (RA) is essential to ensure that pharmac...