Board Description

Carleton University’s MSc in Clinical Trials and Regulatory Affairs is a specialized graduate program that prepares students with the critical knowledge and practical skills for careers in clinical trial research and health product regulation. The program’s curriculum integrates regulatory science, trial methodologies, ethical standards, and data management, equipping students to address health product safety and efficacy complexities.

The program benefits from the strategic guidance of an Advisory Board comprising of distinguished experts in clinical research, regulatory affairs, and academia. This board plays a crucial role in ensuring that the program remains responsive to the evolving landscape of clinical trials, providing insights on regulatory shifts, technological advances, and skill demands. Their input informs curriculum development, aligns the program with industry standards, and enhances learning by fostering a bridge between academic theory and real-world application.

Board members contribute through targeted discussions, identifying industry trends, addressing competency needs, and advising on emerging challenges. The board operates under values of integrity and intellectual rigour, promoting an environment for constructive dialogue and diverse perspectives. This approach supports the program’s adaptive model, allowing it to stay relevant as the field evolves.

With an emphasis on experiential learning and industry alignment, the board’s involvement helps ensure that graduates are well-prepared to make meaningful contributions to clinical trials and regulatory affairs, positively impacting public health and Canada’s clinical trial sector.

Members

Cynthia Rau, MSc

Cindy joins us from PPD / Thermo Fisher and has been in the CRO arena for over 20 years. She is a Senior Director in Project Delivery where she oversees trials with a study team and collaborates closely with the client and executive stakeholders. Cindy’s passion lies with process and governance. She has also been responsible for writing and teaching a Project Management course and has received her International Qualified Clinical Research Professional (IAOCR) Accreditation and holds Lead 6 Sigma Certification.

When not working, she enjoys spending time with her family – husband and two teenage daughters. She also serves on the board of directors of therapeutic (horse back) riding. She aims to keep fit by cycling and can be found teaching an indoor group class, participating in a class, or outdoors when the weather permits.

Chris O’Callaghan, DVM, MSc, PhD

Dr. O’Callaghan received his Doctorate in Veterinary Medicine and MSc and PhD degrees in Epidemiology from the University of Guelph, based on work conducted on the epidemiology of infections of livestock while a Medical Research Council of Canada Fellow at the International Livestock Research Institute in Nairobi, Kenya. He continued is research and training in infectious diseases epidemiology as a Wellcome Trust Senior Research Fellow at the University of Warwick. In 2001, he joined the Canadian Cancer Trials Group where he continues to oversee the Gastrointestinal and Brain Site Committees as Senior Investigator. He is also a Professor in the Department of Public Health Sciences. His research interests are diverse and include clinical trials design and methodology and infectious disease epidemiology.

Carole Légaré, BSc, MD, CCFP, Cert PE & PV

Dr. Carole Légaré completed her medical training and family medicine residency at the University of Ottawa, and her postgraduate pharmacoepidemiology and pharmacovigilance training at the London School of Hygiene and Tropical Medicine in the UK. After gaining experience in clinical practice and public health, she joined Health Canada in 2002 where she initially worked in pharmacovigilance. She also spent a year as a senior medical advisor for the Centre for Biologics Evaluation. In 2013, she joined the Therapeutic Products Directorate (now the Pharmaceutical Drugs Directorate) as the Executive Director of the Office of Clinical Trials, where she oversaw all activities related to the approval and pharmacovigilance of clinical trials involving pharmaceuticals as well as Health Canada’s Special Access Program. She represented Health Canada at the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) where she worked on the development of the ICH E8(R1) guideline “General Considerations for Clinical Studies.” Despite having retired from her Executive position, she continues to work on the development of the ICH E6(R3) guideline on “Good Clinical Practice.”

Adam Gibson

Adam Gibson is a graduate of Queen’s University where he obtained a BScH in Life Sciences. He has been working in the regulatory field of medicines for over 20 years. He is a published author and his experience spans both government and industry work. He is a former Director General of the Natural Health Products program at Health Canada and has federal experience in the oversight of prescription drugs, OTC drugs, clinical trials, natural health products, food, and medical devices. He presently leads his own consulting firm and is a registered federal and provincial lobbyist. Mr. Gibson leverages his experience and world-wide professional contacts to provide service to clients in the health product, patient group, academic, and charity sectors.