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 part two of a three-part series, Jaishankar Kutty, Ph.D. continues 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:
- Challenges in demonstrating safety and performance/efficacy for medical devices
- Differences between FDA and EU approaches to clinical evidence
- The impact of evolving device designs on clinical studies
- Importance of pre-submission meetings with regulatory bodies
- Complexities of the EU reimbursement landscape
- Strategies for dealing with small sample sizes in clinical data
- The shift in the EU regulatory landscape and its impact on manufacturers
Whether you're a seasoned professional or new to the field, this discussion offers crucial perspectives on optimizing your regulatory submission strategy for medical devices and IVDs in both the US and EU markets.
Don't miss this opportunity to learn from top industry experts and enhance your understanding of the regulatory review process in clinical trials!
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