Strategy for First-in-Human Studies (1/2) – MedTech CRO: Strategy Development 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.*

❓ What are the objectives and benefits of conducting 𝗳𝗶𝗿𝘀𝘁-𝗶𝗻-𝗵𝘂𝗺𝗮𝗻 𝘀𝘁𝘂𝗱𝗶𝗲𝘀? What are the key considerations and best practices for manufacturers?

We have answers.

🏥 Here's the first video in our 𝗠𝗲𝗱𝗧𝗲𝗰𝗵 𝗖𝗥𝗢: 𝗦𝘁𝗿𝗮𝘁𝗲𝗴𝘆 𝗗𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁 𝗦𝗲𝗿𝗶𝗲𝘀 – 𝗦𝘁𝗿𝗮𝘁𝗲𝗴𝘆 𝗳𝗼𝗿 𝗙𝗶𝗿𝘀𝘁-𝗶𝗻-𝗛𝘂𝗺𝗮𝗻 𝗦𝘁𝘂𝗱𝗶𝗲𝘀 (𝟭/𝟮). 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.

𝗪𝗮𝘁𝗰𝗵 𝗮𝗻𝗱 𝘆𝗼𝘂 𝘄𝗶𝗹𝗹 𝗹𝗲𝗮𝗿𝗻:

📎 The objectives and benefits of conducting FIH studies

📎 Key considerations and best practices for manufacturers

📎 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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