Understanding the regulatory differences between USA, Australia, and Canada.
According to the US Food and Drug Administration (FDA) Phase 1 clinical trials are an increasing $4-$6 Billion global industry. Nucleus Network has built its business to serve emerging biotech customers which represent the fastest growing part of the global clinical development market, accounting for ~80% of the global drug development pipeline.
With the increase in focus and investment in medical research, has come greater scrutiny on the oversight of clinical trials. While all regulatory bodies offer assurance for this oversight, equally as important for pharmaceutical companies is the variation in timeline, cost, documentation required, and feedback received from different regulators, meaning selecting the optimal trial location could have a substantial impact on the feasibility of bringing a product to market. With different requirements for starting clinical trials depending on the jurisdiction, re-examining current processes and partnerships can offer opportunities for improvement, even in already high-performing operations.
Co-authors and speakers, Dr. Graham Wood has extensive experience with clinical trial administration in the USA and Canada, and his insight is augmented with Biljana Georgievska’s in-depth understanding of the regulatory landscape in Australia, and her experience in conducting clinical trials that comply with global reporting standards, in particular with the FDA and European medicines Agency (EMA).
This Webinar and supporting White Paper look at the differences between the three regulatory bodies, and how speed and cost can both be improved by selecting the right location or mix of locations for your clinical trial, without the need to sacrifice quality.
Presented by
Dr. Graham Wood,
Executive Vice President
Dr. Graham Wood is a leader in the conduct and design of clinical pharmacology studies having held senior executive roles in a number of the top clinical research sites in the world.
In total, he has over 22 years of experience and has been involved with more than 200 first-in-human studies as well as over 2,000 studies across all areas of clinical pharmacology.
After finishing his PhD in Neurology and Neurosurgery, Dr. Wood worked at MDS Pharma Services, Cetero Research, Manna Research and Altasciences as well as spending two years working at biotechnology companies.
Biljana Georgievska,
Director of Clinical Development
An experienced people manager, Biljana Georgievska has extensive global experience in strategic and operations clinical research management, specializing in the development of clinical trials of novel therapeutic cancer therapies and Phase 1 healthy volunteer clinical trials. Her unique ability to engage at all levels, has had an instrumental impact on Nucleus Network’s company culture and employee engagement. Biljana’s in-depth knowledge and understanding of the U.S. market has been instrumental in her ability to relate to the clients of Nucleus Network and in leading and mentoring other people within the company.
