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Clinical Trials Europe
29 - 30 November, 2023
CCIB, Barcelona

Khadija Rantell
Senior Statistical Assessor at Medicines and Health Care Products Regulatory Agency (MHRA), UK

Profile

Dr Khadija Rantell is a Senior Statistical Assessor at the MHRA, where she has been working since 2013.

At the MHRA, she writes assessment reports on methodological aspects of licensing applications, advises companies on methodological aspects of their clinical development programme, and contributes to the assessment of clinical trial applications and clinical investigations of medical devices.

Prior to joining the agency, Khadija worked in academia for over 10 years, where she taught statistics, both at undergraduate and postgraduate levels, and was involved in research across a wide range of therapeutic areas. She has a PhD in Applied Statistics to Healthcare Research from Sheffield University.

Khadija has a particular interest in novel trial designs, patient reported outcomes, real-word-data, and rare diseases. She often participates at the American Statistical Association (ASA) Biopharmaceutical Section (BIOP) open forum discussions, which is run in collaboration with Project Significant (Statistics in Cancer Trials) established by the FDA Oncology Center of Excellence.

Khadija has also collaborated on number of projects where the objective is to improve the design and reporting of early phase trials. She is a member of the Patient Reported Outcomes Specialist Interest Group at the MHRA, the EFSPI (European Federation for Statisticians in the Pharmaceutical Industry) Scientific Committee, and the EFPIA/EFSPI Estimand Implementation Working Group (EIWG).

Agenda Sessions

  • PANEL: Learning's from the Recent Pandemic- How to manage a Pandemic/Crisis Management in the Future

    15:00
  • Regularity Viewpoint from the MHRA on Decentralized Clinical Trials

    11:40