Current position and relevant professional experience:
Solange Corriol-Rohou, a pulmonologist/immuno-allergist by training, joined AstraZeneca R&D in 2004 and is currently Se. 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. 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.
As a board member of EFGCP, involved in the EFGCP Children Medicines Working Party, she has organised 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 organised 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 led the way to optimise the qualification framework.
She also has experience working in public-private partnership projects (IMI PROactive in COPD, ADAPT SMART, U-BIOPRED, Get Real, Trials@Home and MOBILISE-D). Quite recently, she proposed a new project to IHI as part of the Rare Disease Moonshot.
She has also published over 50 scientific papers in peer-reviewed journals, including in the TOPRA Journal, Regulatory Rapporteur.
Current or previous involvement in TOPRA activities:
Active involvement in the TOPRA Board of Directors these last 2 years as well as in TOPRA in France.
For TOPRA In France, we have 2 potential webinars to be organised in the coming months.
I was also recently proposed to join a panel on paediatrics at the 2023 TOPRA Annual Symposium in Lisbon.
Personal statement:
This position is an exciting opportunity to not only share my experience and expertise and meaningfully contribute to TOPRA goals but also to keep the momentum since I have been a TOPRA Board Member these last 2 years.
While I feel I am qualified for this position because of my dedication and achievement record, I do believe I could do more. This is why, if selected I'll be more than happy to discuss the matter and identify what I could be doing next.
Nomination information
Proposer: Solange Corriol-Rohou; Seconders: Gabriel Bohl and Frederic Ivanow