Sponsors are increasingly interested in conducting early phase clinical trials in Australia. This is because of Australia’s strong value proposition, particularly with faster timelines due to a favorable regulatory pathway.
Navigating an unfamiliar regulatory framework can be daunting. That is why many sponsors rely on an experienced partner to guide them through the process.
This webinar will provide clarity on the regulatory requirements in Australia and the differences between the more widely known US process. This webinar will also detail the preclinical data package and chemistry, manufacturing and control (CMC) requirements for the conduct of clinical trials in Australia.
Speaker Dr. Jason Lickliter will outline the approach from preclinical to first patient first dose, which aligns with the International Conference on Harmonization (ICH) package and US Food and Drug Administration (FDA) guidelines. Dr. Jason Lickliter will also discuss the preclinical data package, including toxicology and safety pharmacology study requirements. Dr. Lickliter will be joined by Dr. Jon Fairweather to discuss the CMC requirements for investigational product use in Phase I clinical trials.
This webinar is a must-attend for biotechnology and pharmaceutical companies looking to progress from the preclinical stage. Gain invaluable advice and come away with a solid understanding of:
How Australia’s regulatory framework compares with the US FDA approval process
Preclinical data package and CMC requirements for investigational product use in Phase I clinical trials
General Human Research Ethics Committee (HREC) expectations in study design for first-in-human clinical trials
Why distance is no longer an obstacle to offshoring clinical trials
Register for this webinar to gain the knowledge needed to conduct clinical trials in Australia now.
- How Australia’s regulatory framework compares with the US FDA approval process
- Preclinical data package and CMC requirements for investigational product use in Phase I clinical trials
- General Human Research Ethics Committee (HREC) expectations in study design for first-in-human clinical trials
- Why distance is no longer an obstacle to offshoring clinical trials
This webinar is a must-attend for biotechnology and pharmaceutical companies looking to progress from the preclinical stage, in particular:
- C-Suite (CEO; Chief Technology Officer [CTO]; Chief Medical Officer [CMO])
- Senior Medical Officers and Researchers
- Heads of Research and/or Development
- Operations Personnel
Xtalks Pharmaville
Canberra, District of Canberra Central, Australian Capital Territory, 2600, Australia
