Catherine Cohet
European Medicines Agency, Université de Strasbourg
Research areas: Medicine · Epidemiology · Pharmacovigilance and Adverse Drug Reactions · Cervical Cancer and HPV Research · SARS-CoV-2 and COVID-19 Research
0000-0002-0022-7251
About
Catherine joined the European Medicines Agency in 2020 as a Pharmacoepidemiology Senior Specialist in the real-world evidence (RWE) workstream of the Data Analytics & Methods Task Force, where she focuses on all aspects of RWE generation and use in regulatory decision-making, bringing more than 20 years of experience in (pharmaco)epidemiology across academic, industry, and regulatory settings. Her work includes key roles in International Council for Harmonisation (ICH) guideline development (M14, E6(R3) Annex 2), the design of non-interventional real-world data (RWD) studies, and public health crisis preparedness and response as part of the Steering Group of the EU Vaccine Monitoring Platform. She co-chairs the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP), represents EMA in research projects under the International Coalition of Medicines Regulatory Authorities (ICMRA), and serves as an expert on the WHO Global Advisory Committee on Vaccine Safety. She previously held senior roles in the pharmaceutical industry, generating and evaluating RWE across the development and lifecycle of medicines, worked as an epidemiologist at the Centre for Public Health Research and the Malaghan Institute for Medical Research in Wellington, New Zealand, and as a scientist at the WHO International Agency for Research on Cancer in Lyon, France.
Employment
- 2020 - Present
Education
Projects & Funding
Projects & funding information is unavailable.
Publications (54)
- Immunocompromised Status Definition in Observational Studies Using Electronic Health Records: A Scoping Review and a Proposal for a Phenotype Identification Algorithm Save
- Strengthening Pharmacoepidemiology in a Changing Research Environment: The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) Save
- An extension of the Benefit Risk Assessment of VaccinEs toolkit to evaluate Comirnaty and Spikevax vaccination in the European Union Save
- Utilising the Benefit Risk Assessment of Vaccines (BRAVE) toolkit to evaluate the benefits and risks of Vaxzevria in the EU: a population-based study Save
- Collaborative Real‐World Evidence Among Regulators: Lessons and Perspectives Save
- Relationship between HLA genetic variations, COVID-19 vaccine antibody response, and risk of breakthrough outcomes Save
- Updated core competencies in pharmacoepidemiology to inform contemporary curricula and training for academia, government, and industry Save
- Risk of Arterial and Venous Thrombotic Events Among Patients with COVID-19: A Multi-National Collaboration of Regulatory Agencies from Canada, Europe, and United States Save
- A feasibility assessment of real‐world data capabilities for monitoring vaccine safety and effectiveness in China: Human papillomavirus vaccination in the Yinzhou district as a use case Save
- Assessing heterogeneity of electronic health‐care databases: A case study of background incidence rates of venous thromboembolism Save
- MOnitoring human papillomavirus Vaccine effect on Infection and cErvical diseases (MOVIE): Protocol for a cohort study using electronic health records from Yinzhou, China Save
- Comparative effectiveness of heterologous third dose vaccine schedules against severe covid-19 during omicron predominance in Nordic countries: population based cohort analyses Save
- Safety Monitoring of COVID‐19 Vaccines: Perspective from the European Medicines Agency Save
- Regulation of Vaccines in Europe Save
- Comparative risk of thrombosis with thrombocytopenia syndrome or thromboembolic events associated with different covid-19 vaccines: international network cohort study from five European countries and the US Save
- Impact of bacterial strain acquisition in the lung of patients with COPD: the AERIS study Save
- Marketing Authorization Applications Made to the European Medicines Agency in 2018–2019: What was the Contribution of Real‐World Evidence? Save
- A phase III randomized, open-label, non-inferiority clinical trial comparing liquid and lyophilized formulations of oral live attenuated human rotavirus vaccine (HRV) in Indian infants Save
- Suitability of databases in the Asia‐Pacific for collaborative monitoring of vaccine safety Save
- Effectiveness of “Priorix” Against Measles and Mumps Diseases in Children Born After 2004 in the United Kingdom Save