How to write a good Clinical Study Report (CSR) for FDA submission

Date: April 16, 2025
Duration: 60 Minutes
Time: 12 PM EST

Are you eager to expand your horizons and delve into the world of regulatory documents for the pharmaceutical and biotechnology industries? If so, our exclusive seminar is tailor-made for you, offering the expertise and insights you need to master the art of crafting a top-notch Clinical Study Report (CSR) for FDA submission.
 
Why should you attend:
  1. Gain an in-depth understanding of the critical elements required to captivate your target audience: the FDA or other regulatory agencies.
  2. 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.
  3. 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!​
                                                                        
Who will benefit: 
  1. Regulatory affairs professionals
  2. Senior management executives (CEO, COO, CFO, etc)
  3. Documentation management personnel
  4. Records and storage personnel
  5. Drug discovery and development professionals (R&D and CMC)
  6. Clinical trial managers
  7. Project Managers and Clinical trial specialists
  8. Regulatory Compliance Associates and Managers
  9. 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.

Terms & Conditions to register for the Webinar

Your Registration for the workshop is subject to following terms and conditions. If you need any clarification before registering for this webinar please email us at info@fdamap.com

Payment

We accept credit card, debit card, and PayPal. 

Cancellations & Substitutions:

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.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($30) will be transferred to any future FDA Map event and a credit note will be issued. No-shows will be charged the full amount.

Webinar material will be uploaded on the website 24 hours before the scheduled date of the webinar. In case it is not available on the website due to some technical issues, we will email the material a few hours before the start of the webinar.

In the event FDA Map cancels the webinar, FDA Map will issue a full refund to all the registrants for that webinar. Some topics and speakers may be subject to change without notice.

For any information on the training agenda and logistics, please call +1 410-501-5777 or email: info@fdamap.com