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What makes a successful regulatory submission from a clinical trial perspective? (Part 1/3) – MedTech CRO: Regulatory Expertise Series
*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:
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!
--
📲 Follow RQM+ on LinkedIn.
💼 Check out our open positions.
📚 See on-demand content in our Knowledge Center.
📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use our contact form.
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By RQM+
4.8
3535 ratings
*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:
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!
--
📲 Follow RQM+ on LinkedIn.
💼 Check out our open positions.
📚 See on-demand content in our Knowledge Center.
📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use our contact form.