Strategy for First-in-Human Studies (1/2) โ€“ MedTech CRO: Strategy Development Series - podcast episode cover

Strategy for First-in-Human Studies (1/2) โ€“ MedTech CRO: Strategy Development Series

Jun 05, 2024โ€ข11 min
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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.*


โ“ What are the objectives and benefits of conducting ๐—ณ๐—ถ๐—ฟ๐˜€๐˜-๐—ถ๐—ป-๐—ต๐˜‚๐—บ๐—ฎ๐—ป ๐˜€๐˜๐˜‚๐—ฑ๐—ถ๐—ฒ๐˜€? What are the key considerations and best practices for manufacturers?


We have answers.


๐Ÿฅ Here's the first video in our ๐— ๐—ฒ๐—ฑ๐—ง๐—ฒ๐—ฐ๐—ต ๐—–๐—ฅ๐—ข: ๐—ฆ๐˜๐—ฟ๐—ฎ๐˜๐—ฒ๐—ด๐˜† ๐——๐—ฒ๐˜ƒ๐—ฒ๐—น๐—ผ๐—ฝ๐—บ๐—ฒ๐—ป๐˜ ๐—ฆ๐—ฒ๐—ฟ๐—ถ๐—ฒ๐˜€ โ€“ ๐—ฆ๐˜๐—ฟ๐—ฎ๐˜๐—ฒ๐—ด๐˜† ๐—ณ๐—ผ๐—ฟ ๐—™๐—ถ๐—ฟ๐˜€๐˜-๐—ถ๐—ป-๐—›๐˜‚๐—บ๐—ฎ๐—ป ๐—ฆ๐˜๐˜‚๐—ฑ๐—ถ๐—ฒ๐˜€ (๐Ÿญ/๐Ÿฎ). Join VP of Strategic Regulatory Affairs Sew-Wah Tay and VP of Global Regulatory Affairs Jaishankar Kutty, Ph.D. as they discuss crucial strategic considerations for first-in-human (FIH) studies.


๐—ช๐—ฎ๐˜๐—ฐ๐—ต ๐—ฎ๐—ป๐—ฑ ๐˜†๐—ผ๐˜‚ ๐˜„๐—ถ๐—น๐—น ๐—น๐—ฒ๐—ฎ๐—ฟ๐—ป:


๐Ÿ“Ž The objectives and benefits of conducting FIH studies

๐Ÿ“Ž Key considerations and best practices for manufacturers

๐Ÿ“Ž How to navigate early-stage challenges effectively


Don't miss this strategic guidance that will help you streamline your FIH study process and make informed decisions. Watch now... and stay tuned for part two!



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Strategy for First-in-Human Studies (1/2) โ€“ MedTech CRO: Strategy Development Series | Device Advice by RQM+ podcast - Listen or read transcript on Metacast