Bio Box Australia • Ep 2
COVID-19 Diagnostics, Treatments & Vaccines
VIDEO: Bio Box Australia • Ep 2
The COVID-19 global health emergency has cast a spotlight on the lengthy and complex process of researching, developing and accessing therapies in Australia and around the world. In light of the urgency, stakeholders across the globe have successfully utilised existing fast track mechanisms and developed new ones to allow the rapid approval of clinical trial protocols and evaluation of investigational drugs which had shown therapeutic potential.
This in-depth insights piece covers:
• Introduction to the current and evolving regulatory landscape in response to COVID-19
• Compare and contrast the regulatory and government responses in Australia, the US and Europe to allow emergency use for
• In-Vitro Diagnostics (IVD) – how they are being used to respond to the testing needs as the COVID-19 pandemic emerged and spreads.
• Medicines– changes and lessons in light of off-label prescribing
For each of the above topics, the panel will explore:
• Available regulatory pathways
• Comparative timing in issuing guidance on emergency use
• Accessibility to regulators for guidance