Episode description
Episode description
*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.*
In the final installment of this three-part series, Jaishankar Kutty, Ph.D. concludes the discussion with former FDA lead reviewer Ryan Randall and ex-BSI clinical compliance head Amie Smirthwaite (current RQM+ Senior VP of Scientific Affairs) on the intricacies of successful regulatory submissions in clinical trials.
Key topics covered:
- Critical study design elements that can make or break a regulatory submission
- Navigating global clinical studies and patient population requirements
- The importance of ISO 14155 compliance in EU submissions
- Special considerations for niche and orphan devices
- US Humanitarian Device Exemption (HDE) pathway insights
- Future developments in EU pathways for rare disease technologies
- Strategies for managing studies with limited patient populations
These experts provide crucial insights into avoiding common pitfalls in study design and execution, while offering unique perspectives on specialized regulatory pathways for rare diseases and underserved populations.
Learn how to navigate these complex regulatory landscapes and optimize your submission strategy for success in both US and EU markets.
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