Position: Associate Director - Regulatory Affairs and Pharmacovigilance - IROS CRO
Categories: Speakers 2024

As the Senior Manager of Regulatory Affairs and Pharmacovigilance at Insights Research Organization and Solutions (IROS), Dr Marie leads operations associated with the conduct of clinical trials in accordance with all applicable regulations & study-specific requirements and ensures that research sites are prepared and have the necessary tools needed to start the trial. In addition, her department manages the safety profile of new drugs in clinical trials, oversees case-processing activities through all phases of development, and perform regulatory reporting and medical monitoring tasks

Dr Marie has over 15 years of experience, the last 8 of which have been in Regulatory Affairs including the regulation of clinical research, continuous education, professional licensing, and auditing of health advertisements.

Prior to joining IROS, she headed the Research and Education Regulation Department at Dubai Healthcare City Authority where she oversaw the regulation of human subject research including non-interventional studies and complex clinical trials. She also sat on the IRB of Mohammed Bin Rashid University of Medicine and Health Sciences as the Regulatory Representative.

Dr Marie graduated with a degree of Doctor of Dental Surgery in 2008 and also holds a Master’s Degree in Healthcare Management and a Postgraduate Diploma in Clinical Leadership and Innovation from the Royal College of Surgeons in Ireland.