Helen-Marie Dunmore

ESTP Congress
helen-marie.dunmore@certara.com
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Helen-Marie Dunmore is a Senior Director in Toxicology who has significant experience consulting on the nonclinical regulatory requirements of investigational medicinal products including, large and small molecules and advanced therapies. Prior to consulting, Helen-Marie served as a Senior Nonclinical Reviewer at the Medicines & Healthcare product Regulatory Agency in the UK and as a NonClinical Expert to the European Medicines Agency for just under 10 years. Her role included reviewing nonclinical submission packages in support of clinical trial authorisation applications or marketing authorisation applications across drug modalities and therapy areas. Helen-Marie has experience presenting complex nonclinical findings and making recommendations to Advisory Committees and providing scientific and regulatory advice. She was involved in drafting regulatory guidance and participating in working groups and industry global consortia eg. BioSafe and the Association of British Pharmaceutical Industry and is a European board registered toxicologist.