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A Guide to Preclinical and CMC Requirements for Conducting Clinical Trials in Australia, Upcoming Webinar Hosted by Xtalks

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This webinar is a must-attend for biotechnology and pharmaceutical companies looking to progress from the preclinical stage.


TORONTO (PRWEB)

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.

Featured 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. 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; and 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.

Join Dr. Jason Lickliter, Chief Medical Officer, Nucleus Network; and Dr. Jon Fairweather, Business Development Executive, PCI Pharma Services for Australia and New Zealand, for the live webinar on Thursday, April 28, 2022, at 1pm EDT (10am PDT.)

For more information, or to register for this event, visit A Guide to Preclinical and CMC Requirements for Conducting Clinical Trials in Australia.

ABOUT XTALKS

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life science, food and medical device community. Every year, thousands of industry practitioners (from life science, food and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

To learn more about Xtalks visit http://xtalks.com

For information about hosting a webinar visit http://xtalks.com/why-host-a-webinar/

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