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.*
❓ What are the CGMP principles and traceability requirements for 𝗳𝗶𝗿𝘀𝘁-𝗶𝗻-𝗵𝘂𝗺𝗮𝗻 𝘀𝘁𝘂𝗱𝗶𝗲𝘀? How do you manage device iterations and site selection effectively?
🎬 The second video in our 𝗠𝗲𝗱𝗧𝗲𝗰𝗵 𝗖𝗥𝗢: 𝗦𝘁𝗿𝗮𝘁𝗲𝗴𝘆 𝗗𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁 𝗦𝗲𝗿𝗶𝗲𝘀 – 𝗦𝘁𝗿𝗮𝘁𝗲𝗴𝘆 𝗳𝗼𝗿 𝗙𝗶𝗿𝘀𝘁-𝗶𝗻-𝗛𝘂𝗺𝗮𝗻 𝗦𝘁𝘂𝗱𝗶𝗲𝘀 (𝟮/𝟮) answers these questions. Once again, Jaishankar Kutty, Ph.D. is back with VP of Strategic Regulatory Affairs Sew-Wah Tay.
𝗪𝗮𝘁𝗰𝗵 𝘁𝗼 𝗹𝗲𝗮𝗿𝗻:
📌 The importance of CGMP principles and full traceability for FIH devices
📌 Managing device iterations in a 10-15 patient FIH study
📌 Key considerations for site and physician selection across different geographies
We hope these strategies help you navigate the complexities of FIH studies and ensure success. RQM+ is here to help if you need it.
--
📹 View and share this clip on LinkedIn.
📲 Follow RQM+ on LinkedIn.
💼 Check out our open positions.
📝 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.