Ms. Marianne Vanderwel holds two Master’s degrees in Engineering Physics and in Medical Sciences from McMaster University. Her experience includes: • 10 years of academic research in health sciences • Many years experience in the healthcare industry where she held various positions in diagnostic research and clinical research. • From 1993, Marianne worked in the area of quality management for major pharmaceutical companies with oversight responsibilities related to Good Clinical Practices and pharmacovigilance in Canada and worldwide. • From 2007 to 2015, she was responsible for maintaining an effective Human Research Protection Program at Institutional Review Board Services, an independent ethics committee in Canada. • Since 2007, Marianne has been working as a Quality Management Consultant specializing in promoting quality in clinical research. • She has conducted over 270 audits in her career, including audits of investigators, CROs, and sponsors. She extends her role to the research community by actively participating in industry, academic and regulatory authority collaborations.