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Navigating Regulatory Landmines for Combination Products – MedTech CRO: Regulatory Expertise Series
Manage episode 429329064 series 2688337
*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.*
While she has moved towards retirement since recording this video with Jaishankar Kutty, Ph.D., Nancy Morrison, RAC talks about the regulatory landmines around 𝗰𝗼𝗺𝗯𝗶𝗻𝗮𝘁𝗶𝗼𝗻 𝗽𝗿𝗼𝗱𝘂𝗰𝘁𝘀 in the newest video in our clinical trials series.
𝗪𝗮𝘁𝗰𝗵 𝗳𝗼𝗿 𝗶𝗻𝘀𝗶𝗴𝗵𝘁𝘀 𝗼𝗻:
◽ Determining the regulatory pathway for your combination product
◾ Addressing regulators' primary concerns in submissions
◽ Overcoming clinical trial challenges unique to combination products
◾ Key learnings from real-world cases
Whether developing drug-device combinations, drug-eluting implants, or other innovative combination products, this video offers guidance to help avoid costly delays and regulatory pitfalls.
If you're interested in RQM+ helping you strategically approach combination product development and set your product up for regulatory success, let us know. 📞
Reminder that you can find all of our clinical trial videos in other places, too. 👇
📺 The RQM+ YouTube channel
📧 For support with clinical trials, please contact us directly.
--
📲 Follow RQM+ on LinkedIn.
📝 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.
162 episodes
Manage episode 429329064 series 2688337
*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.*
While she has moved towards retirement since recording this video with Jaishankar Kutty, Ph.D., Nancy Morrison, RAC talks about the regulatory landmines around 𝗰𝗼𝗺𝗯𝗶𝗻𝗮𝘁𝗶𝗼𝗻 𝗽𝗿𝗼𝗱𝘂𝗰𝘁𝘀 in the newest video in our clinical trials series.
𝗪𝗮𝘁𝗰𝗵 𝗳𝗼𝗿 𝗶𝗻𝘀𝗶𝗴𝗵𝘁𝘀 𝗼𝗻:
◽ Determining the regulatory pathway for your combination product
◾ Addressing regulators' primary concerns in submissions
◽ Overcoming clinical trial challenges unique to combination products
◾ Key learnings from real-world cases
Whether developing drug-device combinations, drug-eluting implants, or other innovative combination products, this video offers guidance to help avoid costly delays and regulatory pitfalls.
If you're interested in RQM+ helping you strategically approach combination product development and set your product up for regulatory success, let us know. 📞
Reminder that you can find all of our clinical trial videos in other places, too. 👇
📺 The RQM+ YouTube channel
📧 For support with clinical trials, please contact us directly.
--
📲 Follow RQM+ on LinkedIn.
📝 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.
162 episodes
All episodes
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