How to write a good Clinical Study Report (CSR) for FDA submission
Date: April 16, 2025
Duration: 60 Minutes
Time: 12 PM EST
Why should you attend:
- Gain an in-depth understanding of the critical elements required to captivate your target audience: the FDA or other regulatory agencies.
- Learn how to structure a CSR: Throughout the seminar, we’ll guide you through each section of a CSR, helping you navigate through the introduction and background, experimental methods, description of study subjects, efficacy results, safety results, and conclusions. By the time you complete the seminar, you’ll be a true master at crafting CSRs that leave a lasting impression on regulatory authorities.
- Dive into the nuts and bolts of CSR content: We’ll give you access to study-related materials like case report forms (CRFs), manuals of operations, statistical analysis plans (SAPs), randomization and blinding schemes, tables, listings, and figures (TLFs), as well as data monitoring committee (DMC) minutes and recommendations.
Remember, the goal is not just to write a CSR but to create an impactful CSR that highlights the potential of your research and supports your application for FDA approval. By the end of the seminar, you’ll walk away with the tools, knowledge, and confidence to craft CSRs that catch the eye of regulators and pave the way for your success in the pharmaceutical and biotechnology industries.
Don’t miss this exclusive opportunity to elevate your regulatory writing skills and unlock new career prospects. Sign up for our seminar today and let us guide you on your journey to becoming a proficient and sought-after CSR writer. Your success story begins here!
- Regulatory affairs professionals
- Senior management executives (CEO, COO, CFO, etc)
- Documentation management personnel
- Records and storage personnel
- Drug discovery and development professionals (R&D and CMC)
- Clinical trial managers
- Project Managers and Clinical trial specialists
- Regulatory Compliance Associates and Managers
- People investing in FDA-regulated product development project.
Speaker: Mukesh Kumar
PhD, RAC | CEO, FDAMap
For more info, fill the box below. We will contact you within 24 hrs.
Webinar Fee
Prices are in US Dollars.
The registration fee includes: The live webinar & all related course materials.
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Written cancellations through fax or email (from the person who has registered for this conference) received at least 5 business days prior to the start date of the event will receive a refund — less a $30 administration fee. No cancellations will be accepted — nor refunds issued — within 5 business days before the start date of the event. You may however, choose to substitute the webinar for which you are registered with some other webinar in the future.
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