First-hand Strategic Insights & Actionable Takeaways
Regulators and industry are in general agreement that mutual reliance amongst regulators has been a critical part of meeting health authority requirements as limitations in travel have been in place. Often using mutual reliance, the speed of approval and confirmation of acceptable status of sites supplying vaccines and therapeutics during the Covid pandemic has been unprecedented.
Additionally, on-site inspections are the preferred platform or “Gold Standard” approach to inspections from a practical and legal perspective. However, in situations where proper planning, coordination, and communication are achievable, Remote Interactive Evaluations or other remote/virtual approaches, are effective tools that may play an important part in future regulatory inspections from agencies around the world, particularly as a backlog has been built up due to the pandemic. Virtual communication tools (e.g. Zoom, MS Teams) are fully integrated into society now and are commonly used across the pharmaceutical industry as colleagues successfully navigated a remote environment while maintaining forward progress on the development, manufacture, and distribution of critical therapeutics for the public.
This session aims to explore both
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