Enhancing Regulatory Affairs intelligence for early access and fast-track approvals
Regulatory Affairs has been at the forefront with health authorities to explore submission pathways toward expedited approvals. The complexity and challenges across the industry to assimilate market, competitive, and Health Authority (HA) intelligence has traditionally been a low-tech approach to understand HA expectations leading to delays and potentially inefficient submission strategies.
This session provides insights on potential strategies to apply digital AI-based solutions to accelerate submission strategy.
From this session, you will learn:
- Use cases of accelerated approvals as a result of effective market intelligence, HA communications, and regulatory strategy
- Insights on approaches in the use of AI to gather and assimilate intelligence across source types
- Approaches to advance intelligence that accelerate success rate in approvals