What makes a successful regulatory submission from a clinical trial perspective? (Part 1/3) – MedTech CRO: Regulatory Expertise Series

Device Advice by RQM+

*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 one of a three part series, Jaishankar Kutty, Ph.D. hosts former FDA lead reviewer Ryan Randall and ex-BSI clinical compliance head Amie Smirthwaite (current RQM+ Senior VP of Scientific Affairs) to unpack the intricacies of successful regulatory submissions in clinical trials.

Key topics covered:

1. Essential stakeholders in the clinical trial approval process for both US and EU markets
2. The importance of early engagement with regulatory bodies and payers
3. Reviewer approaches to clinical data sets and benefit-risk analyses
4. Strategies for navigating failed primary endpoints
5. The balance between statistical and clinical significance in regulatory decision-making
6. Differences in approach between MDD and MDR in the EU
7. The impact of study design and protocol adherence on regulatory review

These experts provide invaluable insights into the mindset of regulatory reviewers, offering guidance on how to present clinical data effectively and navigate complex regulatory landscapes.

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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